Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 312
- Locations
- 2
- Primary Endpoint
- Comfort
Study Overview
Brief Summary
The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is a habitual wearer of planned replacement soft 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 monovision, multifocal or toric contact lenses
- •Any grade 2 or greater slit lamp findings
Outcomes
Primary Outcomes
Comfort
Time Frame: Over-all follow-up visits from baseline to 1 month
Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.
Slit Lamp Findings
Time Frame: Over-all follow-up visits from baseline to1 month
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Lens Deposits
Time Frame: Over-all study visits, baseline to 1-month
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
Secondary Outcomes
No secondary outcomes reported