Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%; Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%; Drug: Olopatadine 0.1% Vehicle; Drug: Olopatadine 0.2% Vehicle

• Registration Number: NCT00987272
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Disposition First Posted: 2014-07-31
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• Japanese ethnicity.
• Seasonal Allergic Conjunctivitis--asymptomatic.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patanol+Patanol Vehicle	Olopatadine Hydrochloride Ophthalmic Solution, 0.1%	Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
Patanol+Patanol Vehicle	Olopatadine 0.1% Vehicle	Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
Pataday+Pataday Vehicle	Olopatadine 0.2% Vehicle	Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
Pataday+Pataday Vehicle	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%	Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye

Primary Outcome Measures

Name	Time	Method
Mean Ocular Itching Score	Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary Outcome Measures

Name	Time	Method
Mean Total Redness Score	Day 0 of treatment: 3, 10, 20 minutes post-CAC