Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

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

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

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