Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

Vistakon Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Allergic Conjunctivitis

Treatments

Drug: R89674 0.025% ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00364091

06-003-09

Details and patient eligibility

About

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Enrollment

365 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

history of positive diagnostic test for ragweed within the past 2 years;
positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion criteria

ocular infection;
history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
moderate to severe asthma;
dry eye syndrome;
history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
pregnancy or lactation