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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