Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Overview
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
Full Title of Study: “A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2008
Interventions
- Drug: Elestat
- Elestat BID for 2 days
- Drug: Pataday
- Pataday QD for 2 days
Arms, Groups and Cohorts
- Experimental: Elestat
- Active Comparator: Pataday
Clinical Trial Outcome Measures
Primary Measures
- Change in Ocular Itch Score From Baseline
- Time Frame: 0 hours, 12 hours
- Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.
Secondary Measures
- Ocular Comfort Score at 12 Hours
- Time Frame: 12 hours
- Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.
Participating in This Clinical Trial
Inclusion Criteria
- Documented history of ocular allergy to cats. – Positive skin prick allergen reaction to cat dander. Exclusion Criteria:
- Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study. – History of severe asthma, reactive airway disease or bronchial obstruction. – Ocular surgery or trauma in the last year.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Michael Raizman, MD, Principal Investigator, Ophthalmic Consultants of Boston
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