Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
NCT ID: NCT00836485
Last Updated: 2023-08-04
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
PHASE2
122 participants
INTERVENTIONAL
2009-02-28
2009-03-31
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
TREATMENT
DOUBLE
Study Groups
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1
Ketotifen 4.0% Patch
Ketotifen 4.0% Patch
This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
2
Placebo Patch
Placebo
The control is a placebo patch that contains only the inactive ingredients of ketotifen.
3
Pataday(TM)
Olopatadine 0.2%
1 gtt/eye on two separate occasions
4
Placebo eye drops
Artificial tears
1 gtt/eye on two separate occasions
Interventions
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Ketotifen 4.0% Patch
This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
Placebo
The control is a placebo patch that contains only the inactive ingredients of ketotifen.
Olopatadine 0.2%
1 gtt/eye on two separate occasions
Artificial tears
1 gtt/eye on two separate occasions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
* able and willing to avoid all disallowed medication for the washout period and during the study
Exclusion Criteria
* ocular surgery within the past 3 months
* pregnancy or nursing
18 Years
ALL
No
Sponsors
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Senju USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Torkildsen, MD
Role: PRINCIPAL_INVESTIGATOR
ORA, Inc.
TBD TBD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Ora
Andover, Massachusetts, United States
Countries
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Other Identifiers
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SNJ-ALK201/08-003-11
Identifier Type: -
Identifier Source: org_study_id
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