NCT01240122
Completed
Not Applicable
Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
ConditionsCorneal Staining
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Optics
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Corneal Staining by Wear Time
Overview
Brief Summary
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •were at least 18 years old;
- •were experienced contact lens wearers;
- •were correctable to at least 20/40 or better in both eyes with contact lenses;
- •were in good general health, with healthy eyes (other than requiring vision correction);
- •had not worn lenses for at least 12 hours before each baseline visit;
- •had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
- •had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion Criteria
- •had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
- •required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
- •had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
- •were currently participating in any other clinical study;
- •had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Outcomes
Primary Outcomes
Corneal Staining by Wear Time
Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.
Secondary Outcomes
- Subjective Solution Preference(Day 4)
- Overall Ocular Comfort(Day 4)
Investigators
Study Sites (1)
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