Clinical Evaluation of a Silicone Hydrogel Lens
Not Applicable
Completed
- Conditions
- Myopia
- Registration Number
- NCT01016132
- Lead Sponsor
- CIBA VISION
- Brief Summary
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
- Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
- Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
- Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
- Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria
- Eye injury or surgery within 12 months prior to enrollment.
- Currently enrolled in any clinical trial.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall Preference 4 weeks of wear Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
- Secondary Outcome Measures
Name Time Method