NCT00531375CompletedNot Applicable
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
University of Melbourne1 site in 1 country60 target enrollmentStarted: September 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Melbourne
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
- •Is a current full time soft contact lens wearer.
- •Has no clinically significant anterior eye findings.
- •Has no other active ocular disease
Exclusion Criteria
- •Has any systemic disease that might interfere with contact lens wear
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any pre-existing ocular irritation that would preclude contact lens fitting.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- •Has undergone corneal refractive surgery.
- •Is pregnant, lactating or planning a pregnancy.
- •Is participating in a concurrent clinical trial.
- •Has a latex sensitivity.
Investigators
Study Sites (1)
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