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Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

V

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

NCT00244543
05-003-13

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

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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