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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Senju USA, Inc.
• Treatments: Ketotifen; Lubricant Eye Drops; Olopatadine Hydrochloride; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• active ocular infection or skin condition

• ocular surgery within the past 3 months

• pregnancy or nursing