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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00534794

Purpose

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 IV

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:

MedlinePlus related topics: Allergy Pinkeye

Drug Information available for: Epinastine Epinastine hydrochloride Olopatadine Patanol

U.S. FDA Resources

Further study details as provided by Merck:

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

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534794

Locations

United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Merck

Investigators

Principal Investigator:

Michael Raizman, MD

Ophthalmic Consultants of Boston

More Information

No publications provided

Responsible Party:	Inspire Pharmaceuticals
ClinicalTrials.gov 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:	June 7, 2011
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinastine
Olopatadine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012