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Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Vistakon Pharmaceuticals Identifier:
First received: October 25, 2005
Last updated: September 26, 2011
Last verified: September 2011
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Single-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

Resource links provided by NLM:

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: 110
Study Start Date: October 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Please refer to this study by its identifier: NCT00244543

United States, Massachusetts
North Andover, Massachusetts, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
Study Director: Ingerman Avner, MD Johnson & Johnson
  More Information

Responsible Party: Vistakon Pharmaceuticals Identifier: NCT00244543     History of Changes
Other Study ID Numbers: 05-003-13
Study First Received: October 25, 2005
Last Updated: September 26, 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 processed this record on August 16, 2017