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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pataday+Pataday Vehicle

Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Olopatadine 0.2% Vehicle

Intervention Type DRUG

Inactive ingredients used as placebo comparator

Patanol+Patanol Vehicle

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye

Group Type ACTIVE_COMPARATOR

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%

Intervention Type DRUG

Olopatadine 0.1% Vehicle

Intervention Type DRUG

Inactive ingredients used as placebo comparator

Interventions

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Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%

Intervention Type DRUG

Olopatadine 0.2% Vehicle

Inactive ingredients used as placebo comparator

Intervention Type DRUG

Olopatadine 0.1% Vehicle

Inactive ingredients used as placebo comparator

Intervention Type DRUG

Other Intervention Names

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PATADAY® PATANOL®

Eligibility Criteria

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Inclusion Criteria

* Japanese ethnicity.
* Seasonal Allergic Conjunctivitis--asymptomatic.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No