Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

This study is ongoing, but not recruiting participants.

First Received: August 11, 2006 Last Updated: September 1, 2006 History of Changes

Sponsored by:	Vistakon Pharmaceuticals
Information provided by:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00364091

Purpose

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: R89674 0.025% ophthalmic solution	Phase III

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

Ocular itching and redness scores at defined timepoints

Secondary Outcome Measures:

QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints

Estimated Enrollment:	331
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

history of positive diagnostic test for ragweed within the past 2 years; positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion Criteria:

ocular infection; history of retinal detachment, diabetic neuropathy, or any progressive retinal disease; moderate to severe asthma; dry eye syndrome; history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease; pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364091

Locations

United States, Kentucky

Louisville, Kentucky, United States
United States, Massachusetts

North Andover, Massachusetts, United States
United States, Missouri

Creve Coeur, Missouri, United States
United States, North Carolina

Charlotte, North Carolina, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
United States, Tennessee

Memphis, Tennessee, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators

Study Director:

Reza Haque, MD

Vistakon Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	06-003-09
Study First Received:	August 11, 2006
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00364091 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vistakon Pharmaceuticals:

allergic conjunctivitis, ophthalmology, multicenter, controlled

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 06, 2009