Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort (NCT00349843) | Clinical Trial Compass
CompletedPhase 4
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
Canada30 participantsStarted 2005-06
Plain-language summary
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
✓. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
✓. Is correctable to a visual acuity of 6/6 or better with their habitual correction.
✓. Is willing and able to follow product usage instructions and maintain the visit schedule.
✓. Is at least 18 years of age and has full legal capacity to volunteer.
✓. Can be successfully fitted with study lens type.
✓. Has read, understood and signed an Information Consent Letter.
✓. Has a distance contact lens prescription is between -0.50 D and -9.00 D
Exclusion criteria
✕. Has any active ocular disease.
✕. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
✕. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
✕. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
What they're measuring
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The primary objective of this study is to compare corneal staining over time in
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a group of individuals who wear soft contact lenses on a daily wear basis,
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whilst they sequentially use two different contact lens care regimens.