Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis - Full Text View

Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

This study is ongoing, but not recruiting participants.

Sponsored by:	Vistakon Pharmaceuticals
Information provided by:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00241319

Purpose

The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: R89674 (generic name not yet established)	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

Ocular itching and conjunctival redness post challenge

Secondary Outcome Measures:

Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge

Estimated Enrollment:	150
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction

Exclusion Criteria:

narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241319

Locations


United States, Indiana

	Indianapolis, Indiana, United States

United States, Maine

	Lewiston, Maine, United States

United States, New York

	Rochester, New York, United States

United States, North Carolina

	Charlotte, North Carolina, United States

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators


Study Director:	Ingerman Avner, MD	Johnson & Johnson

More Information

Study ID Numbers:	05-003-11
First Received:	October 14, 2005
Last Updated:	June 11, 2006
ClinicalTrials.gov Identifier:	NCT00241319
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vistakon Pharmaceuticals:

ocular, allergic conjunctivitis, ophthalmic

Study placed in the following topic categories:

Hypersensitivity

Conjunctivitis, Allergic

Eye Diseases

Hypersensitivity, Immediate

Conjunctivitis

Conjunctival Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 17, 2008