Status:
COMPLETED
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Alcon Research
Conditions:
Myopia
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 se...
Eligibility Criteria
Inclusion
- 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
- Has astigmatism of ≤ 1.00 D Cyl
- Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
- Has no systemic disease affecting ocular health.
- Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
- Has clear corneas and no active ocular disease.
- Has no known ocular or systemic allergies, which could interfere with contact lens wear.
- Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
- Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
- Has not worn extended wear contact lenses in the last 30 days.
- Has had an oculo-visual examination in the last two years
Exclusion
- 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)
- Is using topical ocular prescription or any topical over-the-counter medication.
- Is actively involved in any other research/clinical study.
- Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
- Has had corneal refractive surgery.
- Has known sensitivity to any of the study solutions.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00349843
Start Date
June 1 2005
Last Update
December 16 2015
Active Locations (1)
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1
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1