Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 20, 2007
Last updated: April 27, 2015
Last verified: April 2015
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Condition Intervention Phase
Allergic Conjunctivitis
Drug: Elestat
Drug: Pataday
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Ocular Itch Score From Baseline [ Time Frame: 0 hours, 12 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Ocular Comfort Score at 12 Hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.

Enrollment: 79
Study Start Date: October 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elestat Drug: Elestat
Elestat BID for 2 days
Active Comparator: Pataday Drug: Pataday
Pataday QD for 2 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00534794

United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Principal Investigator: Michael Raizman, MD Ophthalmic Consultants of Boston
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00534794     History of Changes
Other Study ID Numbers: 031-408 
Study First Received: September 20, 2007
Results First Received: January 30, 2009
Last Updated: April 27, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Drug Hypersensitivity
Chemically-Induced Disorders
Conjunctival Diseases
Drug-Related Side Effects and Adverse Reactions
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 26, 2016