A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Not Applicable
Completed
- Conditions
- Presbyopia
- Registration Number
- NCT01539694
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
- Have physiologically normal anterior segments.
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
Exclusion Criteria
- Any Grade 2 or greater finding during the slit lamp examination.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study products.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Visual Acuity At 1 week follow up Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
- Secondary Outcome Measures
Name Time Method Symptoms/Complaints At 1 week follow up Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Trial Locations
- Locations (1)
Bausch & Lomb Incorporated
🇺🇸Rochester, New York, United States
Bausch & Lomb Incorporated🇺🇸Rochester, New York, United States