Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00241319
First received: October 14, 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 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

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: 150
Study Start Date: October 2005
Primary Completion Date: December 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:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00241319     History of Changes
Other Study ID Numbers: 05-003-11
Study First Received: October 14, 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, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014