Corneal and Conjunctival Sensitivity and Staining Study
Overview
- Phase
- Phase 4
- Intervention
- Optifree RepleniSH Multipurpose Disinfecting Solution
- Conditions
- Myopia
- Sponsor
- University of Waterloo
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Corneal Sensitivity
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.
Detailed Description
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.
Investigators
Eligibility Criteria
Inclusion Criteria
- •An eligible participant is one who:
- •Is between 17-45 years old and has full legal capacity to volunteer.
- •Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
- •Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
- •Has normal binocular vision (no strabismus, no amblyopia).
- •Has clear corneas and no active ocular disease.
- •Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
- •Has astigmatism less than or equal to -1.00DC.
Exclusion Criteria
- •A person is ineligible if he/she:
- •Has undergone corneal refractive surgery.
- •Is aphakic.
- •Has any active ocular disease.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that may affect ocular health.
- •Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- •Is pregnant or lactating.
- •Is participating in any other clinical or research study.
- •Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
Arms & Interventions
Optifree RepleniSH Multipurpose Disinfecting Solution
Intervention: Optifree RepleniSH Multipurpose Disinfecting Solution
ReNu Multiplus Multipurpose Solution
Intervention: ReNu Multiplus Multipurpose Solution
Outcomes
Primary Outcomes
Corneal Sensitivity
Time Frame: day 7
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Conjunctival Sensitivity
Time Frame: day 7
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Secondary Outcomes
- Corneal Staining Grade(day 7)