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
55 participants
INTERVENTIONAL
2005-07-31
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
DOUBLE
Interventions
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soft contact lens
Soft contact lens multipurpose disinfection regimen
Eligibility Criteria
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Inclusion Criteria
2. Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian's permission to participate in the study and has read the Information and Consent Letter for adolescents.
4\. Has read and understood the Information Consent Letter (Appendix II). 5. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
6\. Has a refractive error that is correctable with the prescription of the available study lenses.
7\. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
8\. Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered "normal".
Exclusion Criteria
2. Is using any systemic or topical medications that may affect ocular health.
3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
4. Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
5. Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
6. Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
7. Has refractive astigmatism of more than 0.75 D.
8. Has corneal distortion resulting from rigid lens wear.
9. Is aphakic.
10. Has undergone corneal refractive surgery.
11. Is participating in any other type of clinical or research study.
12. Is pregnant or lactating.
16 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/217/05/L
Identifier Type: -
Identifier Source: org_study_id