Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle; Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

• Registration Number: NCT00331500
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-18
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Primary Completion: 2006-07-27
• Study Completion: 2006-07-27
• Status Verified: 2008-06
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria

• Under 10 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Olopatadine Hydrochloride Ophthalmic Solution Vehicle	Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks
Olopatadine Hydrochloride 0.2%	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%	Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks

Primary Outcome Measures

Name	Time	Method
Daily ocular itching and redness scores	Up to Day 14

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with daily ocular itching and redness scores of 0	Up to Day 14