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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534794
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : May 27, 2009
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Elestat Drug: Pataday Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model
Study Start Date : October 2007
Actual Primary Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Elestat Drug: Elestat
Elestat BID for 2 days

Active Comparator: Pataday Drug: Pataday
Pataday QD for 2 days

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Ocular Comfort Score at 12 Hours [ Time Frame: 12 hours ]
    Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534794

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

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00534794    
Other Study ID Numbers: 031-408
First Posted: September 26, 2007    Key Record Dates
Results First Posted: May 27, 2009
Last Update Posted: May 13, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Drug Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action