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Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis. - NCT00770133-(Clinical Trial 246388)



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City:  North Andover
State:  
MA
Zip Code:
Conditions: Allergic Conjunctivitis
Purpose: The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
Study summary:
Criteria: Inclusion Criteria: - Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. - Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart. - Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1. - Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2. Exclusion Criteria: - Known contraindications or sensitivities to the study medication or its components. - Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. - Use of disallowed medications during the period indicated prior to study enrollment or during the study.
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Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
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