Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00244543
First received: October 25, 2005
Last updated: September 26, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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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: NCT00244543

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

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00244543     History of Changes
Other Study ID Numbers: 05-003-13
Study First Received: October 25, 2005
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 22, 2014