Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
Study Details
Study Description
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 sequentially use two different contact lens care regimens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- The primary objective of this study is to compare 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. []
Secondary Outcome Measures
- The secondary objective of this study is to compare subjective ocular symptoms []
- 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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
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Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
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Is correctable to a visual acuity of 6/6 or better with their habitual correction.
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Is willing and able to follow product usage instructions and maintain the visit schedule.
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Is at least 18 years of age and has full legal capacity to volunteer.
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Can be successfully fitted with study lens type.
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Has read, understood and signed an Information Consent Letter.
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Has a distance contact lens prescription is between -0.50 D and -9.00 D
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Has astigmatism of ≤ 1.00 D Cyl
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Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
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Has no systemic disease affecting ocular health.
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Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
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Has clear corneas and no active ocular disease.
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Has no known ocular or systemic allergies, which could interfere with contact lens wear.
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Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
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Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
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Has not worn extended wear contact lenses in the last 30 days.
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Has had an oculo-visual examination in the last two years
Exclusion Criteria:
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Has any active ocular disease.
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Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
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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.)
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Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
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Is using topical ocular prescription or any topical over-the-counter medication.
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Is actively involved in any other research/clinical study.
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Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
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Has had corneal refractive surgery.
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Has known sensitivity to any of the study solutions.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Contact Lens Research, University of Waterloo | Waterloo | Ontario | Canada | N2L 3G1 |
Sponsors and Collaborators
- University of Waterloo
- Alcon Research
Investigators
- Principal Investigator: Craig Woods, PhD, University of Waterloo
- Principal Investigator: Desmond Fonn, MOptom, University of Waterloo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P/211/04/L