Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
NCT ID: NCT00520689
Last Updated: 2009-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2007-09-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
Silicone Hydrogel Contact Lens
use of lens over 2 days
2
Silicone Hydrogel Contact Lens
use of lens over 2 days
3
Silicone Hydrogel Contact Lens
use of lens over 2 days
4
Silicone Hydrogel Contact Lens
use of lens over 2 days
Interventions
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Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Is at least 17 years old and has full legal capacity to volunteer
2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
3. Is willing and able to follow instructions and maintain the study appointment schedule
4. Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
6. Has clear corneas and no active ocular disease
7. Has had an ocular examination in the last two years.
8. Has a functional pair of spectacles
9. Is a current soft lens wearer replacing their lenses at least monthly
10. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
11. Has astigmatism less than or equal to -1.00DC
12. Agrees to wear the study lenses on a daily wear basis
Exclusion Criteria
1. Has any signs or symptoms of dry eye
2. Has any clinically significant blepharitis
3. Has undergone corneal refractive surgery
4. Is aphakic
5. Has any systemic disease affecting ocular health
6. Is using any systemic or topical medications that may affect ocular health
7. Is pregnant or lactating
8. Is participating in any other type of clinical or research study
9. Currently wears daily disposable lenses
10. Currently wears lenses on a continuous or extended wear basis
11. Is unable to successfully wear contact lenses without routinely using rewetting drops
17 Years
55 Years
ALL
Yes
Sponsors
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Menicon Co., Ltd.
INDUSTRY
University of Waterloo
OTHER
Responsible Party
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CCLR
Principal Investigators
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Desmond Fonn, M Optom
Role: PRINCIPAL_INVESTIGATOR
University of Waterloo
Craig Woods, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Waterloo
Locations
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Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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P/264/07/M
Identifier Type: -
Identifier Source: org_study_id
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