Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
Phase 3
Completed
- Conditions
- Allergic Conjunctivitis
- Registration Number
- NCT00241319
- Lead Sponsor
- Vistakon Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ocular itching and conjunctival redness post challenge
- Secondary Outcome Measures
Name Time Method Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge