Overview
ISO 11980:2012 - "Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations" provides international guidance for planning, conducting and reporting clinical investigations (CIs) that assess the safety and performance of contact lenses and contact lens care products. The standard aligns CI requirements with good clinical practice (referencing ISO 14155) and aims to harmonize regulatory expectations worldwide for pre‑market and post‑market studies.
Key topics and technical requirements
- Scope and purpose: Guidance for clinical investigation plans (CIPs) to support marketing, labelling and special claims (e.g., comfort, compatibility).
- Normative references: ISO 14155 (clinical investigation of medical devices), ISO 14534 (fundamental requirements) and ISO 18369‑1 (vocabulary, classification and labelling).
- Study design:
- Prospective, concurrently controlled studies are preferred for lenses and care products; designs include inter‑subject controls, contra‑lateral eye (intra‑subject) or bilateral crossover.
- Historical (uncontrolled) comparisons allowed if well‑characterized and compatible.
- Randomization and masking (subject, investigator, evaluator) recommended where possible.
- Subject selection:
- Inclusion/exclusion criteria tied to study objectives (e.g., age, ocular health, refractive limits, recent participation in other trials).
- Special considerations when studies target pediatric indications or post‑surgical/irregular cornea indications.
- Statistical and monitoring requirements:
- A pre‑determined statistical analysis plan, including sample size calculations using validated software, is mandatory.
- CIP must describe monitoring procedures and adverse event reporting (serious ophthalmic adverse events require special case report forms).
- Variables and endpoints:
- For contact lenses: visual and refractive performance, lens centration/movement, surface wettability/deposits, subject acceptance (vision, comfort, handling).
- For care products: corneal oedema, infiltrates, staining, vascularization, conjunctival and palpebral observations, ulcers, scarring, etc.
- Annexes: Informative guidance on CI design (Annex A), ocular safety evaluations (Annex B) and visual/refractive performance classifications (Annex C).
- Suggested sample sizes and durations: Table guidance includes examples (e.g., 30 completed subjects for many daily‑wear studies; larger cohorts and longer durations for extended/overnight wear; 3‑month CI recommended for products with new active ingredients).
Practical applications and users
Who uses ISO 11980:2012:
- Contact lens and contact lens care product manufacturers preparing clinical evidence for regulatory submissions and labelling claims.
- Clinical investigators, CROs and study designers developing CIPs that follow good clinical practice.
- Regulatory authorities and notified bodies evaluating safety/performance data.
- Product development teams validating compatibility of solutions with specific lens materials.
Practical uses:
- Designing controlled clinical trials, defining endpoints, justifying sample size and duration.
- Structuring adverse event monitoring and reporting processes.
- Demonstrating product compatibility with lens types and supporting comfort/efficacy claims.
Related standards
- ISO 14155 - Clinical investigation of medical devices for human subjects - Good clinical practice
- ISO 14534 - Ophthalmic optics - Fundamental requirements
- ISO 18369‑1 - Contact lenses - Vocabulary, classification and labelling
Keywords: ISO 11980:2012, clinical investigation, contact lenses, contact lens care products, clinical investigation plan, ISO 14155, safety and performance, sample size, study design, adverse events.
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