NCT00636194CompletedNot Applicable
Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
Bausch & Lomb Incorporated2 sites in 1 country361 target enrollmentStarted: February 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 361
- Locations
- 2
- Primary Endpoint
- Subjective Assessment of Comfort and Cleanliness
Study Overview
Brief Summary
To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish 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
- •Subjects are adapted wearers of silicone hydrogel contact lenses
- •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 a monovision, multifocal or toric contact lenses
- •Any grade 2 or greater slit lamp findings
Outcomes
Primary Outcomes
Subjective Assessment of Comfort and Cleanliness
Time Frame: 7 days
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Secondary Outcomes
- Symptoms and Complaints(2 weeks)
- Graded Slit Lamp Findings > Grade 2(2 week follow-up visit)
Investigators
Study Sites (2)
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