Status:
COMPLETED
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Collaborating Sponsors:
Alcon Research
Conditions:
Contact Lens Solution Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00829751
Start Date
November 1 2008
End Date
June 1 2011
Last Update
June 4 2013
Active Locations (1)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831