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

This study has been completed.

First Received: September 20, 2007 Last Updated: April 3, 2009 History of Changes

Sponsor:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
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:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Change in Ocular Itch Score From Baseline [ Time Frame: 0 hours, 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ocular Comfort Score at 12 Hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	October 2007
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Elestat: Experimental	Drug: Elestat
Pataday: Active Comparator	Drug: Pataday

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Inspire Pharmaceuticals

Investigators

Principal Investigator:

Michael Raizman, MD

Ophthalmic Consultants of Boston

More Information

No publications provided

Study ID Numbers:	031-408
Study First Received:	September 20, 2007
Results First Received:	January 30, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00534794 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on November 27, 2009