Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
NCT ID: NCT00569777
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2007-10-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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K-lens
etafilcon A contact lens with ketotifen.
K-Lens (generic name not established) and Ketotifen
combination drug-device product: contact lens (device) and anti-allergy drug
Placebo
etafilcon A contact lens without ketotifen
Placebo Lens
contact lens without drug
Interventions
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K-Lens (generic name not established) and Ketotifen
combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lens
contact lens without drug
Eligibility Criteria
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Inclusion Criteria
* normal ocular health
* contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye
Exclusion Criteria
* history of ocular surgery
* use of topical ophthalmic preparations (including rewetting drops)
* pregnancy or lactation
8 Years
ALL
Yes
Sponsors
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Vistakon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Pall, OD, MS, FAAO
Role: STUDY_DIRECTOR
Johnson & Johnson Vision Care, Inc.
Locations
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Gardena, California, United States
North Andover, Massachusetts, United States
Memphis, Tennessee, United States
Countries
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Other Identifiers
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07-003-002
Identifier Type: -
Identifier Source: org_study_id
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