Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 541
- Locations
- 2
- Primary Endpoint
- Slit-lamp Findings > Grade 2
Study Overview
Brief Summary
To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subject is a habitual wearer of a silicone hydrogel or group IV contact lens
- •VA correctable to 0.3 LogMar or better (driving vision)
- •Clear central cornea
- •Subject uses a lens care system on a regular basis
Exclusion Criteria
- •Systemic disease affecting ocular health
- •Using systemic or topical medications
- •wear monovision, multifocal or toric contact lenses
- •Any grade 2 or greater slit lamp findings
Outcomes
Primary Outcomes
Slit-lamp Findings > Grade 2
Time Frame: Over 4 visits for 3 month period
eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
Subjective Responses to Comfort Related Symptoms/Complaints
Time Frame: Over 4 visits for the 3 month period
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Contact Lens Deposits
Time Frame: At each visit for 3 months
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
Secondary Outcomes
No secondary outcomes reported