Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations
Not Applicable
- Conditions
- Corneal Epithelial DisruptionCorneal Staining
- Registration Number
- NCT00381446
- Lead Sponsor
- Andrasko, Gary, OD, LLC
- Brief Summary
The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.
- Detailed Description
A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
- correct visual acuity of 20/30 or better each eye
Exclusion Criteria
- history of hypersensitivity to any components of solution being tested
- any ocular condition prohibiting contact lens wear
- excessive baseline staining as defined in protocol
- use of topical or OTC ocular medications during the study
- seasonal allergies with significant effect on contact lens wear
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area of Corneal Staining
- Secondary Outcome Measures
Name Time Method Type (severity) of Corneal Staining
Trial Locations
- Locations (1)
Dr. Richard Erdey office
🇺🇸Columbus, Ohio, United States