A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Antimicrobial Efficacy
Study Overview
Brief Summary
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
- •Must be able and willing to comply with all treatment and follow-up study procedures.
- •Must have a clear central cornea.
- •VA correctable to 0.3 LogMar or better (driving vision)
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.
- •Pregnancy
Arms & Interventions
Multipurpose Solution
Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
Intervention: Bausch & Lomb Multi-Purpose Solution (Device)
Outcomes
Primary Outcomes
Antimicrobial Efficacy
Time Frame: 2 weeks, 3 months
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
Secondary Outcomes
- Solution Related AE's and Lens Changes(3 months, 6 months)
- Solution Utlility(3 months, 6 months)