Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 175
- Locations
- 2
- Primary Endpoint
- Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Study Overview
Brief Summary
The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Soft contact lens wear on a daily wear basis
- •Able to wear contact lenses for at least 8 hours
- •Generally healthy and have normal ocular health
- •Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- •No use of additional lens cleaners
- •No known sensitivities to any ingredient in the test article
- •No history of ocular surgery/trauma within the last six months
- •Other protocol-defined exclusion criteria may apply
Outcomes
Primary Outcomes
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Time Frame: Baseline (Day 0), Day 30
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Time Frame: Baseline (Day 0), Day 30
Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20.
Secondary Outcomes
No secondary outcomes reported