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Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00241319
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : September 27, 2011
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: R89674 (generic name not yet established) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2005
Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Primary Outcome Measures :
  1. Ocular itching and conjunctival redness post challenge

Secondary Outcome Measures :
  1. Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241319

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
Study Director: Ingerman Avner, MD Johnson & Johnson

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00241319     History of Changes
Other Study ID Numbers: 05-003-11
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Vistakon Pharmaceuticals:
ocular, allergic conjunctivitis, ophthalmic

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions