Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

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

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-18

Study Completion Date

2006-07-27

Brief Summary

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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.

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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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Olopatadine Hydrochloride 0.2%

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Vehicle

Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks

Group Type PLACEBO_COMPARATOR

Olopatadine Hydrochloride Ophthalmic Solution Vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo comparator

Interventions

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Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Olopatadine Hydrochloride Ophthalmic Solution Vehicle

Inactive ingredients used as a placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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