Clinical study of a range of soft contact lens brands
Not Applicable
- Conditions
- Myopia, astigmatism, hyperopia, presbyopiaEye Diseases
- Registration Number
- ISRCTN12617867
- Lead Sponsor
- CooperVision Inc Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
1. Age 8 to 75 years (inclusive).
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent
3. Current wearer (for at least 6 months) of CE-marked CooperVision test or control lenses. Equivalent private-label contact lenses can be included in either group
Exclusion Criteria
Participation in a contact lens or contact lens care product clinical trial within the previous 30 days
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Visual performance (visual acuity) measured based on high-contrast visual acuity at one timepoint<br>2. Incidence of contact lens-related adverse events measured using subject reports and slit lamp evaluation
- Secondary Outcome Measures
Name Time Method Relationship determination between lens fit, surface measurements, and subjective scores measured using appropriate statistical modeling, slit lamp evaluation, and VAS/ISO Questionnaires at one timepoint