A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Vistakon Pharmaceuticals0 sites365 target enrollmentAugust 2006

ConditionsAllergic Conjunctivitis

DrugsR89674 0.025% ophthalmic solution

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Allergic Conjunctivitis
Sponsor: Vistakon Pharmaceuticals
Enrollment: 365
Primary Endpoint: Ocular itching and redness scores at defined timepoints
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

October 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vistakon Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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