Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
NCT ID: NCT00520351
Last Updated: 2010-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2007-08-31
2008-12-31
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
DOUBLE
Study Groups
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1
ClearCare
contact lens care system
2
Optifree Replenish
contact lens care system
Interventions
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ClearCare
contact lens care system
Optifree Replenish
contact lens care system
Eligibility Criteria
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Inclusion Criteria
1. Is at least 17 years of age and has full legal capacity to volunteer.
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 presently using either bi-weekly or monthly replacement lenses.
5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
7. Has clear corneas and no active ocular disease.
8. Has had an ocular examination in the last two years.
Exclusion Criteria
1. Is an asymptomatic lens wearer.
2. Is a daily disposable contact lens wearer.
3. Is a current extended wear contact lens wearer.
4. Currently uses one of the study lens care regimens.
5. Has any clinically significant blepharitis.
6. Has undergone corneal refractive surgery.
7. Is aphakic.
8. Has any active ocular disease.
9. Has any systemic disease affecting ocular health.
10. Is using any systemic or topical medications that may affect ocular health.
11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
12. Is participating in any other type of clinical or research study.
17 Years
ALL
Yes
Sponsors
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Alcon Research
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
Locations
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Centre for Contact Lens Research, School of Optometry, University of Waterloo.
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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P/265/07/L
Identifier Type: -
Identifier Source: org_study_id