Effects of Contact Lens Care Regimens on the Corneal Epithelium
NCT ID: NCT00349882
Last Updated: 2006-07-10
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
PHASE4
30 participants
INTERVENTIONAL
2005-06-30
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
DOUBLE
Interventions
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soft contact lens
Marketed multipurpose disinfection regimen
Eligibility Criteria
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Inclusion Criteria
2. Has read, understood and signed an Information Consent Letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual 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 2 years.
8. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.
An ineligible contact lens wearer is one who:
9. Responds positively to points 1 to 7 above.
10. Has a distance contact lens prescription between -0.50D and -9.00 D.
11. Has astigmatism less than or equal to -1.00D cyl.
12. Currently wears silicone hydrogel contact lenses successfully.
13. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.
Exclusion Criteria
2. Is aphakic.
3. Has any active ocular disease.
4. Has any systemic disease affecting ocular health.
5. Is using any systemic or topical medications that may affect ocular health.
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
7. Is pregnant or lactating.
8. Is participating in any other type of clinical or research study.
An ineligible contact lens wearer is one who:
10. Has known sensitivity to the contact lens care solutions used in the study.
11. Has ocular or systemic allergies that could adversely affect contact lens wear.
12. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
13. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
University of Waterloo
OTHER
Principal Investigators
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Craig Woods, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Waterloo
Desmond Fonn, MOptom
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/216/05/L
Identifier Type: -
Identifier Source: org_study_id