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

Tracking Information

First Received Date ^ICMJE

September 20, 2007

Last Updated Date

April 3, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change in ocular itch score from baseline [ Time Frame: 1 day ]

Change History

Complete list of historical versions of study NCT00534794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Ocular comfort score [ Time Frame: 1 day ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: Elestat
Drug: Pataday

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00534794

Responsible Party

Study ID Numbers ^ICMJE

031-408

Study Sponsor ^ICMJE

Inspire Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael Raizman, MD

Ophthalmic Consultants of Boston

Information Provided By

Inspire Pharmaceuticals

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP