Overview
ISO 11980:2025 - Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations - sets out requirements and guidance for designing and conducting clinical investigations (CIs) to establish the safety and performance of contact lenses and contact lens care products. The standard aligns recognised regulatory expectations for clinical trials across jurisdictions while noting that national regulations take precedence. It provides detailed guidance on study design, clinical assessment variables, data collection, and reporting to support marketing, labelling and regulatory submissions.
Key technical topics and requirements
- Scope and purpose
- Defines CI objectives for contact lenses and lens care products, including additional considerations for indications beyond refractive correction.
- Clinical investigation plan (CIP)
- Requires a monitoring procedure, a pre‑specified statistical analysis plan and statistically justified sample size.
- Participant selection
- Inclusion and exclusion criteria tied to study objectives (age ranges, refractive range, visual acuity thresholds, ocular health conditions, prior clinical trial participation windows).
- Study design
- Preferred designs: prospective, concurrently controlled studies (bilateral crossover, parallel groups, or contra‑lateral eye designs).
- Bilateral studies preferred over contralateral because of inter-eye dependence and compliance concerns.
- Uncontrolled/historical controls permitted when a well‑characterised clinical database exists.
- Randomisation and masking (participant, investigator, evaluator) recommended where possible.
- Contact lens care product specifics
- Daily wear schedules generally recommended; a 1–2 hour post‑dispensing visit is suggested when safety is a primary objective.
- Objective measurement of lens deposits required for cleaners/cleaning claims.
- Compatibility claims with specific lens types must be supported pre‑clinically and clinically; absence of data must be declared on the label.
- Assessment variables
- Visual acuity, refractive performance, anterior segment evaluations, physiological performance and subjective assessments (further guidance in Annexes).
- Supporting materials
- Annex A: elements of a CI and study design guidance
- Annex B: grading scales for ocular evaluation
- Annex C: visual, refractive and subjective performance evaluation
Practical applications and users
- Manufacturers and sponsors planning clinical trials for new contact lenses or care products
- Clinical investigators and study designers developing CIPs and statistical plans
- Regulatory and quality teams preparing submissions, labelling claims or demonstrating compatibility claims
- Notified bodies and regulators assessing clinical evidence for market clearance
Related standards
- ISO 14155 - Clinical investigation of medical devices - Good clinical practice
- ISO 14534 - Fundamental requirements for contact lenses and care products
- ISO 18369‑1 - Vocabulary, classification and labelling recommendations
Keywords: ISO 11980:2025, clinical investigation, contact lenses, contact lens care products, clinical investigation plan (CIP), safety and performance, clinical trials, study design, statistical analysis plan, visual acuity.
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