Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

Vistakon Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Allergic Conjunctivitis

Treatments

Drug: R89674 (generic name not yet established)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241319

05-003-11

Details and patient eligibility

About

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

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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