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

Vistakon Pharmaceuticals0 sites150 target enrollmentOctober 2005

ConditionsAllergic Conjunctivitis

DrugsR89674 (generic name not yet established)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Allergic Conjunctivitis
Sponsor: Vistakon Pharmaceuticals
Enrollment: 150
Primary Endpoint: Ocular itching and conjunctival redness post challenge
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

December 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vistakon Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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