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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 26, 2007
Last Update Posted: May 13, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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
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

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 ]
    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 ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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.
ClinicalTrials.gov Identifier: NCT00534794     History of Changes
Other Study ID Numbers: 031-408
First Submitted: September 20, 2007
First Posted: September 26, 2007
Results First Submitted: January 30, 2009
Results First Posted: May 27, 2009
Last Update Posted: May 13, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Drug Hypersensitivity
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
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