Assessment of Lotrafilcon A Contact Lenses
Not Applicable
Completed
- Conditions
- Myopia
- Registration Number
- NCT01185834
- Lead Sponsor
- CIBA VISION
- Brief Summary
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria
- Have normal ocular findings.
- Be able to wear the study lenses in the available powers.
- Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
- Wear Night & Day contact lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Require concurrent ocular medication.
- Eye injury or surgery within twelve weeks prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Any active corneal infection.
- Corneal refractive surgery.
- Wear AIR OPTIX NIGHT & DAY AQUA lenses.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall Comfort 3 months of wear, replacing lenses monthly As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
- Secondary Outcome Measures
Name Time Method Overall Lens Fit 3 months of wear, replacing lenses monthly As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight