Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Allergic Conjunctivitis

• Registration Number: NCT00364091
• Lead Sponsor: Vistakon Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Primary Completion: 2006-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ocular itching and redness scores at defined timepoints

Secondary Outcome Measures

Name	Time	Method
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints