ISO 11980:2012
(Main)Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.
Optique ophtalmique — Lentilles de contact et produits d'entretien pour lentilles de contact — Directives pour les investigations cliniques
L'ISO 11980:2012 donne des lignes directrices pour l'investigation clinique concernant la sécurité et les performances des lentilles de contact et des produits d'entretien pour lentilles de contact.
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FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11980
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses and
Secretariat: DIN
contact lens care products — Guidance
Voting begins on:
for clinical investigations
2012-07-26
Voting terminates on:
Optique ophtalmique — Lentilles de contact et produits d’entretien pour
2012-09-26
lentilles de contact — Directives pour les investigations cliniques
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR
TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 11980:2012(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2012
ISO/FDIS 11980:2012(E)
Copyright notice
This ISO document is a Draft International Standard and is copyrightprotected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced,
stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording
or otherwise, without prior written permission being secured.
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved
ISO/FDIS 11980:2012(E)
ISO/CEN PARALLEL PROCESSING
This Minor Revision has been developed within the International Organization for Standardization (ISO),
and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This final draft is hereby submitted to a parallel two-month approval vote in ISO and three-month UAP vote
in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
ISO/FDIS 11980:2012(E)
Contents Page
Foreword . v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Clinical investigational requirements . 1
4.1 General . 1
4.2 Additional requirements . 1
4.3 Other considerations . 4
Annex A (informative) Elements of a clinical investigation . 5
Annex B (informative) Procedures for the evaluation of safety, physiological performance and effect on
ocular tissues .18
Annex C (informative) The evaluation of visual, refractive and lens performance and
subject acceptance .23
Bibliography .26
iv © ISO 2012 – All rights reserved
ISO/FDIS 11980:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11980 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 11980:2009), which has undergone minor
revision in order to update the normative reference to ISO 14155 and to revise 4.2.1.1 b) and the fifth row of
Table A.1 (overnight wear).
ISO/FDIS 11980:2012(E)
Introduction
Currently, contact lenses and contact lens care products are regulated in different ways in different countries.
This International Standard has been developed to encourage global harmonization. Widespread adoption
of this International Standard should represent yet another step toward mutual recognition. This International
[1]
Standard can also be used as a basis to fulfil design elements of ISO 9001 .
vi © ISO 2012 – All rights reserved
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 11980:2012(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Guidance for clinical investigations
1 Scope
This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of
contact lenses and contact lens care products.
NOTE This International Standard attempts to harmonize the recognized regulatory requirements for the conduct of
a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world.
However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement,
this requirement takes precedence over this International Standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14534, Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
ISO 183691, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14155, ISO 14534 and ISO 183691 apply.
4 Clinical investigational requirements
4.1 General
The general requirements for a CI and for a clinical investigation plan (CIP) given in ISO 14155 shall apply, with
additional requirements given below.
4.2 Additional requirements
4.2.1 Study design
4.2.1.1 General
a) The inclusion criteria for subject selection shall relate to the study objectives and should include:
1) subjects with normal eyes who are not using any ocular medications, aged 18 years or over [except
when contact lens investigations have a special indication for use in “children” (for the purposes of
this International Standard, persons less than 18 years of age) such as orthokeratology and paediatric
aphakic lenses];
2) lens powers within the range available for the test lenses;
3) the manifest cylinder less than or equal to 0,75 D (for a study with only spherical power correcting lenses);
ISO/FDIS 11980:2012(E)
4) best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0,1).
b) The exclusion criteria for subject selection shall relate to the study objectives and should include, but not
be limited to:
1) anterior segment infection, inflammation or abnormality;
2) any active anterior segment ocular disease that would contraindicate contact lens wear;
3) the use of systemic or ocular medications that would contraindicate contact lens wear;
4) history of herpetic keratitis;
5) history of refractive surgery or irregular cornea (except when the contact lenses under investigation
are indicated for irregular cornea, keratoconus or refractive surgery);
6) slit lamp findings that are more serious than grade 1;
7) corneal vascularization greater than 1 mm of penetration;
8) a pathologically dry eye;
9) participation of the subject in a contact lens or contact lens care product clinical trial within the
previous 30 days.
c) The CIP shall provide a description of the monitoring procedure to ensure consistent quality of data
collection and recording.
d) The CIP shall include a statistical analysis plan. Sample size shall be justified, calculated by a validated
statistical software package.
4.2.1.2 Contact lenses
4.2.1.2.1 General. A CI of contact lenses, including daily wear and extended wear hydrogel, silicone hydrogel,
and rigid gaspermeable contact lenses, shall be designed as one of 4.2.1.2.2 or 4.2.1.2.3.
For CIPs to demonstrate safety and performance, as well as special claims (e.g. comfort), labelling or
additional indications, the following is required: a predetermined statistical analysis plan (including sample
size calculations) shall be specified in the clinical protocol. Where feasible, the CIP shall define objective
endpoints to help support such claims.
NOTE 1 Intersubject controls are preferred to intrasubject controls due to the potential dependence between the two
eyes and concerns regarding subject compliance.
NOTE 2 Annex A provides guidance for the design of a CI.
4.2.1.2.2 As a prospective, concurrently controlled study. For investigations evaluating hydrogel, silicone
hydrogel or rigid gaspermeable contact lenses, a prospective, concurrent control study design shall be followed.
Either a bilateral crossover design or a contralateral eye (i.e. intrasubject) design or intersubject controls shall
be utilized. If intersubject controls are utilized, the ratio of test subjects to control subjects may be either 2:1 or
1:1. The control lens shall be a currently marketed contact lens in use for the same modality. Randomization
and masking (subject, investigator and evaluator) shall be employed where possible to minimize the potential
for bias. Subjects shall be divided evenly between study investigators.
4.2.1.2.3 As an uncontrolled study. Here, results are compared to a historical control. Alternative
investigational study designs, such as historical controls, shall be utilized when a sponsor has a clinical database
on a marketed contact lens to use as a comparator. If any historical control is used, the control group shall be
defined and adequately characterized for comparison to the test group. Compatibility of test and control groups
shall be demonstrated by comparison of the selection criteria, demographics, refractive characteristics, contact
lens wearing history and CIPs used.
2 © ISO 2012 – All rights reserved
ISO/FDIS 11980:2012(E)
4.2.1.3 Contact lens care products
For investigations evaluating contact lens care products, a prospective concurrent control study design shall be
followed. It is recommended that the ratio of test to control subjects be either 2:1 or 1:1. The control care product
shall be a currently marketed contact lens care product. Randomization and masking (subject, investigator and
evaluator) shall be employed where possible to minimize the potential for bias. Subjects shall be divided evenly
between study investigators. Alternative investigational study designs, such as use of historical controls, may be
utilized when a manufacturer has a clinical database on a marketed care product to use for comparison. If any
historical control is used, the control group should be defined and adequately characterized for comparison to
the test group. Compatibility of test and control groups should be demonstrated by comparison of the selection
criteria and CIPs used.
For CIPs to demonstrate safety and performance, as well as special claims (e.g. comfort), labelling or additional
indications, the following is required for the care products: a predetermined statistical analysis plan (including
sample size calculations) shall be specified in the clinical protocol. Where feasible, the protocol should define
objective endpoints to help support such claims.
NOTE 1 Intersubject controls are preferred to intrasubject controls due to the potential dependence between the two
eyes and concerns regarding subject compliance.
In a contact lens care product investigation, a daily wear schedule shall be followed f
...
INTERNATIONAL ISO
STANDARD 11980
Third edition
2012-11-15
Ophthalmic optics — Contact lenses and
contact lens care products — Guidance
for clinical investigations
Optique ophtalmique — Lentilles de contact et produits d’entretien pour
lentilles de contact — Directives pour les investigations cliniques
Reference number
©
ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Clinical investigational requirements . 1
4.1 General . 1
4.2 Additional requirements . 1
4.3 Other considerations . 4
Annex A (informative) Elements of a clinical investigation . 5
Annex B (informative) Procedures for the evaluation of safety, physiological performance and effect on
ocular tissues .18
Annex C (informative) The evaluation of visual, refractive and lens performance and
subject acceptance .23
Bibliography .26
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11980 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 11980:2009), which has undergone minor
revision in order to update the normative reference to ISO 14155 and to revise 4.2.1.1 b) 6) and the fifth row of
Table A.1 (overnight wear).
This corrected version of ISO 11980:2012 incorporates the following correction:
— in Table A.12, the final equation corresponding to the total number of eyes has been inserted.
iv © ISO 2012 – All rights reserved
Introduction
Currently, contact lenses and contact lens care products are regulated in different ways in different countries.
This International Standard has been developed to encourage global harmonization. Widespread adoption
of this International Standard should represent yet another step toward mutual recognition. This International
[1]
Standard can also be used as a basis to fulfil design elements of ISO 9001 .
INTERNATIONAL STANDARD ISO 11980:2012(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Guidance for clinical investigations
1 Scope
This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of
contact lenses and contact lens care products.
NOTE This International Standard attempts to harmonize the recognized regulatory requirements for the conduct of
a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world.
However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement,
this requirement takes precedence over this International Standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14534, Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14155, ISO 14534 and ISO 18369-1 apply.
4 Clinical investigational requirements
4.1 General
The general requirements for a CI and for a clinical investigation plan (CIP) given in ISO 14155 shall apply, with
additional requirements given below.
4.2 Additional requirements
4.2.1 Study design
4.2.1.1 General
a) The inclusion criteria for subject selection shall relate to the study objectives and should include:
1) subjects with normal eyes who are not using any ocular medications, aged 18 years or over [except
when contact lens investigations have a special indication for use in “children” (for the purposes of
this International Standard, persons less than 18 years of age) such as orthokeratology and paediatric
aphakic lenses];
2) lens powers within the range available for the test lenses;
3) the manifest cylinder less than or equal to 0,75 D (for a study with only spherical power correcting lenses);
4) best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0,1).
b) The exclusion criteria for subject selection shall relate to the study objectives and should include, but not
be limited to:
1) anterior segment infection, inflammation or abnormality;
2) any active anterior segment ocular disease that would contraindicate contact lens wear;
3) the use of systemic or ocular medications that would contraindicate contact lens wear;
4) history of herpetic keratitis;
5) history of refractive surgery or irregular cornea (except when the contact lenses under investigation
are indicated for irregular cornea, keratoconus or refractive surgery);
6) slit lamp findings that are more serious than grade 1;
7) corneal vascularization greater than 1 mm of penetration;
8) a pathologically dry eye;
9) participation of the subject in a contact lens or contact lens care product clinical trial within the
previous 30 days.
c) The CIP shall provide a description of the monitoring procedure to ensure consistent quality of data
collection and recording.
d) The CIP shall include a statistical analysis plan. Sample size shall be justified, calculated by a validated
statistical software package.
4.2.1.2 Contact lenses
4.2.1.2.1 General. A CI of contact lenses, including daily wear and extended wear hydrogel, silicone hydrogel,
and rigid gas-permeable contact lenses, shall be designed as one of 4.2.1.2.2 or 4.2.1.2.3.
For CIPs to demonstrate safety and performance, as well as special claims (e.g. comfort), labelling or
additional indications, the following is required: a pre-determined statistical analysis plan (including sample
size calculations) shall be specified in the clinical protocol. Where feasible, the CIP shall define objective
endpoints to help support such claims.
NOTE 1 Inter-subject controls are preferred to intra-subject controls due to the potential dependence between the two
eyes and concerns regarding subject compliance.
NOTE 2 Annex A provides guidance for the design of a CI.
4.2.1.2.2 As a prospective, concurrently controlled study. For investigations evaluating hydrogel, silicone
hydrogel or rigid gas-permeable contact lenses, a prospective, concurrent control study design shall be followed.
Either a bilateral crossover design or a contra-lateral eye (i.e. intra-subject) design or inter-subject controls shall
be utilized. If inter-subject controls are utilized, the ratio of test subjects to control subjects may be either 2:1 or
1:1. The control lens shall be a currently marketed contact lens in use for the same modality. Randomization
and masking (subject, investigator and evaluator) shall be employed where possible to minimize the potential
for bias. Subjects shall be divided evenly between study investigators.
4.2.1.2.3 As an uncontrolled study. Here, results are compared to a historical control. Alternative
investigational study designs, such as historical controls, shall be utilized when a sponsor has a clinical database
on a marketed contact lens to use as a comparator. If any historical control is used, the control group shall be
defined and adequately characterized for comparison to the test group. Compatibility of test and control groups
shall be demonstrated by comparison of the selection criteria, demographics, refractive characteristics, contact
lens wearing history and CIPs used.
2 © ISO 2012 – All rights reserved
4.2.1.3 Contact lens care products
For investigations evaluating contact lens care products, a prospective concurrent control study design shall be
followed. It is recommended that the ratio of test to control subjects be either 2:1 or 1:1. The control care product
shall be a currently marketed contact lens care product. Randomization and masking (subject, investigator and
evaluator) shall be employed where possible to minimize the potential for bias. Subjects shall be divided evenly
between study investigators. Alternative investigational study designs, such as use of historical controls, may be
utilized when a manufacturer has a clinical database on a marketed care product to use for comparison. If any
historical control is used, the control group should be defined and adequately characterized for comparison to
the test group. Compatibility of test and control groups should be demonstrated by comparison of the selection
criteria and CIPs used.
For CIPs to demonstrate safety and performance, as well as special claims (e.g. comfort), labelling or additional
indications, the following is required for the care products: a pre-determined statistical analysis plan (including
sample size calculations) shall be specified in the clinical protocol. Where feasible, the protocol should define
objective endpoints to help support such claims.
NOTE 1 Inter-subject controls are preferred to intra-subject controls due to the potential dependence between the two
eyes and concerns regarding subject compliance.
In a contact lens care product investigation, a daily wear schedule shall be followed for most products in order
to maximize the subject’s exposure to those products. However, a study of a lens or a periodic cleaner, used
at weekly intervals, may provide more valuable clinical data concerning efficacy when extended wear subjects
are enrolled than a similar investigation with daily wear subjects.
When a daily wear schedule is used and safety is a primary objective, one post-dispensing visit should be done
1 h to 2 h after lens insertion in order to permit observation of corneal and conjunctival staining caused by an
immediate toxicity reaction.
A contact lens care product with a cleaning indication shall have an objective measure of lens cleanliness on
at least one lens collected from each subject at the end of the clinical study.
If the manufacturer of a contact lens care product wishes to recommend its use with a specific type of lens in
the labelling, the compatibility with the lens type should be confirmed pre-clinically and during the clinical trial.
If the CI has not collected any data on use with a particular type of lens material (such as silicone hydrogel
lenses), the product label should clearly state this fact.
NOTE 2 Annex A provides guidance for the design of a CI.
4.2.2 Variables
4.2.2.1 Contact lenses
The following variables should be considered during the CI for contact lenses, in addition
...
NORME ISO
INTERNATIONALE 11980
Troisième édition
2012-11-15
Optique ophtalmique — Lentilles de
contact et produits d’entretien pour
lentilles de contact — Directives pour
les investigations cliniques
Ophthalmic optics — Contact lenses and contact lens care products —
Guidance for clinical investigations
Numéro de référence
©
ISO 2012
DOCUMENT PROTÉGÉ PAR COPYRIGHT
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous
quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l’accord écrit
de l’ISO à l’adresse ci-après ou du comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2012 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction . v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Exigences relatives à l’investigation clinique . 1
4.1 Généralités . 1
4.2 Exigences supplémentaires . 1
4.3 Autres éléments pris en considération . 5
Annexe A (informative) Éléments d’une investigation clinique . 6
Annexe B (informative) Modes opératoires d’évaluation de la sécurité, des performances
physiologiques et des effets sur les tissus oculaires .19
Annexe C (informative) Évaluation des performances visuelles et réfractives, de l’efficacité des lentilles
et de leur degré de tolérance chez le sujet .24
Bibliographie .27
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux de
normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général confiée aux
comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du comité
technique créé à cet effet. Les organisations internationales, gouvernementales et non gouvernementales,
en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec la Commission
électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI, Partie 2.
La tâche principale des comités techniques est d’élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur publication
comme Normes internationales requiert l’approbation de 75 % au moins des comités membres votants.
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de droits
de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable de ne pas avoir
identifié de tels droits de propriété et averti de leur existence.
L’ISO 11980 a été élaborée par le comité technique ISO/TC 172, Optique et photonique, sous-comité SC 7,
Optique et instruments ophtalmiques.
Cette troisième édition annule et remplace la deuxième édition (ISO 11980:2009), qui a subi des modifications
e
mineures afin d’actualiser la référence normative ISO 14155, et de réviser 4.2.1.1 b) et la 5 rangée du
Tableau A.1, «Port nocturne».
iv © ISO 2012 – Tous droits réservés
Introduction
Actuellement, les lentilles de contact et les produits d’entretien pour lentilles de contact font l’objet de
réglementations différentes selon les pays. La présente Norme internationale a été élaborée pour encourager
une harmonisation globale. Il convient que l’adoption de la présente Norme internationale constitue une étape
supplémentaire vers une reconnaissance mutuelle. La présente Norme internationale peut également servir
[1]
de base pour satisfaire aux éléments de conception de l’ISO 9001 .
NORME INTERNATIONALE ISO 11980:2012(F)
Optique ophtalmique — Lentilles de contact et produits
d’entretien pour lentilles de contact — Directives pour
les investigations cliniques
1 Domaine d’application
La présente Norme internationale donne des lignes directrices pour l’investigation clinique concernant la
sécurité et les performances des lentilles de contact et des produits d’entretien pour lentilles de contact.
NOTE La présente Norme internationale a pour objet d’harmoniser les exigences réglementaires reconnues pour
l’élaboration des données cliniques afin de répondre aux exigences de commercialisation et d’étiquetage des lentilles de
contact et des produits d’entretien pour lentilles de contact au niveau mondial. Cependant, les exigences nationales varient
considérablement. Partout où les pratiques ou réglementations nationales déterminent certaines exigences légales, ces
exigences priment sur la présente Norme internationale.
2 Références normatives
Les documents de référence suivants sont indispensables à l’application du présent document. Pour les
références datées, seule l’édition citée s’applique. Pour les références non datées, la dernière édition du
document de référence s’applique (y compris les éventuels amendements).
ISO 14155, Investigation clinique des dispositifs médicaux pour sujets humains — Bonnes pratiques cliniques
ISO 14534, Optique ophtalmique — Lentilles de contact et produits d’entretien des lentilles de contact —
Exigences fondamentales
ISO 18369-1, Optique ophtalmique — Lentilles de contact — Partie 1: Vocabulaire, système de classification
et recommandations pour l’étiquetage des spécifications
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l’ISO 14155, l’ISO 14534 et
l’ISO 18369-1 s’appliquent.
4 Exigences relatives à l’investigation clinique
4.1 Généralités
Les exigences générales relatives à l’investigation clinique (IC) et au plan d’investigation clinique (PIC) données
dans l’ISO 14155 doivent s’appliquer, avec les exigences supplémentaires mentionnées ci-dessous.
4.2 Exigences supplémentaires
4.2.1 Conception de l’étude
4.2.1.1 Généralités
a) Les critères d’inclusion relatifs au choix des sujets doivent être liés aux objectifs de l’étude et il convient d’inclure:
1) les sujets aux yeux normaux ne faisant pas usage de traitement médical oculaire, âgés de 18 ans
ou plus [sauf lorsque les investigations cliniques de lentilles de contact indiquent spécifiquement que
l’optique ophtalmique et les produits associés peuvent être utilisés avec des sujets mineurs (donc,
pour les besoins de la présente Norme internationale, âgés de moins de 18 ans), par exemple dans le
cas de l’orthokératologie et des lentilles de correction de l’aphakie à usage pédiatrique];
2) les lentilles relevant de la gamme disponible pour les lentilles d’essai;
3) un cylindre de réfraction inférieur ou égal à 0,75 D (pour une étude avec uniquement des lentilles de
correction sphériques);
4) une meilleure acuité visuelle corrigée des lunettes supérieure ou égale à 20/25 (inférieure ou égale
à LogMAR 0,1).
b) Les critères d’exclusion relatifs au choix des sujets doivent être liés aux objectifs de l’étude et il convient
d’inclure sans toutefois s’y limiter:
1) toute infection, inflammation ou anormalité des segments antérieurs;
2) tout trouble oculaire évolutif des segments antérieurs pour lequel le port de lentilles de contact
serait déconseillé;
3) l’utilisation de produits de traitement systémique ou oculaire pour laquelle le port de lentilles de contact
serait déconseillé;
4) les antécédents de toute kératite herpétique;
5) les antécédents de toute chirurgie réfractive ou de toute cornée irrégulière (sauf dans les cas où les
lentilles de contact examinées peuvent être portées par un sujet ayant une cornée irrégulière, atteint
de kératocône ou ayant subi une opération de chirurgie réfractive);
6) des observations à la lampe à fente de gravité supérieure au grade 1;
7) une vascularisation de la cornée d’une pénétration supérieure à 1 mm;
8) les cas de sécheresse oculaire pathologique;
9) les cas où un sujet a participé à un test clinique sur des lentilles de contact ou des produits d’entretien
pour lentilles de contact au cours des 30 derniers jours.
c) Le plan d’investigation clinique (PIC) doit fournir une description de la procédure de surveillance qui permet
de garantir une cohérence de la qualité de collecte et d’enregistrement des données.
d) Le PIC doit comporter un plan d’analyse statistique. L’effectif de l’échantillon doit être justifié, calculé par
un logiciel de statistique validé.
4.2.1.2 Lentilles de contact
4.2.1.2.1 Généralités. Une investigation clinique des lentilles de contact, y compris les lentilles de contact à
port quotidien et les lentilles de contact en hydrogel, en silicone-hydrogel et rigides perméables au gaz à port
prolongé, doit revêtir l’une des formes décrites en 4.2.1.2.2 ou 4.2.1.2.3.
Un plan d’analyse statistique prédéterminé (comportant les calculs de l’effectif d’échantillon) doit être spécifié
dans le protocole clinique afin que le PIC puisse démontrer que la sécurité et les performances des lentilles,
ainsi que les revendications spéciales (par exemple confort), l’étiquetage ou des indications complémentaires
font l’objet de propositions. Le PIC doit définir, lorsque la pratique le permet, des résultats objectifs permettant
de satisfaire à ces revendications.
NOTE 1 Les témoins inter-sujets sont préférés aux témoins intra-sujets en raison de la dépendance éventuelle entre
les deux yeux et des préoccupations relatives à la conformité des témoins.
NOTE 2 L’Annexe A fournit des recommandations pour la conception d’une investigation clinique.
4.2.1.2.2 Étude prospective à contrôle simultané. Une étude prospective à contrôle simultané doit être
adoptée pour les investigations qui se proposent d’évaluer les lentilles de contact en hydrogel, en silicone-
2 © ISO 2012 – Tous droits réservés
hydrogel et rigides perméables au gaz. Une étude croisée bilatérale ou des témoins avec yeux controlatéraux
[c’est-à-dire que les sujets inclus dans l’étude sont aussi les témoins (témoins intra-sujets)], des témoins de
contrôle ou des témoins inter-sujets (c’est-à-dire que les témoins ne sont pas inclus dans l’étude) doivent être
utilisés. Si les témoins inter-sujets sont utilisés, le rapport sujets d’essai-sujets témoins peut être de 2:1 ou 1:1.
La lentille témoin doit être une lentille de contact, actuellement disponible dans le commerce, employée pour
la même modalité. Une répartition aléatoire et un masquage (sujet, examinateur et évaluateur) doivent être
appliqués dans toute la mesure du possible afin de réduire le risque d’erreur au minimum. Les sujets doivent
être répartis de manière égale entre les examinateurs de l’étude.
4.2.1.2.3 Étude non soumise à contrôle. Dans ce cas, les résultats sont comparés à un contrôle antérieur.
Des études d’investigation alternatives, telles que des contrôles d’antécédents, doivent être appliquées lorsqu’un
promoteur dispose d’une base de données clinique sur une lentille de contact commercialisée destinée à être
utilisée comme comparateur. Lorsqu’il est procédé à un contrôle antérieur, le groupe témoin doit être défini et
caractérisé de manière appropriée afin d’être comparé au groupe expérimental. La compatibilité des groupes
expérimentaux et des groupes témoins doit être démontrée par une comparaison des critères de sélection, des
données démographiques, des caractéristiques de réfraction, des antécédents de port des lentilles de contact
et des PIC utilisés.
4.2.1.3 Produits d’entretien pour lentilles de contact
Une étude prospective à contrôle simultané doit être adoptée pour les investigations qui se proposent d’évaluer
les produits d’entretien pour lentilles de contact. Il est recommandé que le rapport sujets d’essai-sujets témoins
soit égal à 2:1 ou 1:1. Le produit d’entretien témoin doit être un produit d’entretien pour lentilles de contact
actuellement disponible dans le commerce. Une répartition aléatoire et un masquage (sujet, examinateur et
évaluateur) doivent être appliqués dans toute la mesure du possible afin de réduire le risque d’erreur au
minimum. Les sujets doivent être répartis de manière égale entre les examinateurs de l’étude. Des études
d’investigation alternatives, telles que des contrôles antérieurs, peuvent être appliquées lorsqu’un fabricant
dispose d’une base de données clinique sur un produit d’entretien commercialisé destiné à être utilisé à des
fins de comparaison. Lorsqu’il est procédé à un contrôle antérieur, il convient de définir le groupe témoin et de
le caractériser de manière appropriée afin d’être comparé au groupe expérimen
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