Status:
COMPLETED
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
Lead Sponsor:
Senju USA, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.
Eligibility Criteria
Inclusion
- 18 years of age of either sex and any race
- 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
- active ocular infection or skin condition
- ocular surgery within the past 3 months
- pregnancy or nursing
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00836485
Start Date
February 1 2009
End Date
March 1 2009
Last Update
August 4 2023
Active Locations (1)
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1
Ora
Andover, Massachusetts, United States, 01810