NCT00244543CompletedPhase 3
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
Vistakon Pharmaceuticals1 site in 1 country110 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Ocular itching and conjunctival redness post challenge
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Ocular itching and conjunctival redness post challenge
Secondary Outcomes
- Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
Investigators
Study Sites (1)
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