The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Not Applicable
Completed
- Conditions
- Contact Lens Solution Toxicity
- Registration Number
- NCT00829751
- Lead Sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Brief Summary
The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- At least 18 years of age.
- Best correctable vision to 20/40 in each eye.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
- No known ocular or systemic allergies, which may interfere with contact lens wear.
- No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).
Exclusion Criteria
- Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
- Are taking part in any other study or have taken part in a study within the last 14 days.
- Are pregnant, or anticipating to become pregnant during the course of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints On day of experiment
- Secondary Outcome Measures
Name Time Method Corneal staining level post lens wear On day of study
Trial Locations
- Locations (1)
Southern California College of Optometry
🇺🇸Fullerton, California, United States
Southern California College of Optometry🇺🇸Fullerton, California, United States