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

Alcon Research267 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

267

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%DRUG

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%DRUG

Olopatadine 0.2% VehicleDRUG

Inactive ingredients used as placebo comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese ethnicity. * Seasonal Allergic Conjunctivitis--asymptomatic. * Other protocol-defined inclusion criteria may apply. 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.

Outcomes

Primary Outcomes

Mean Ocular Itching Score

Time frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary Outcomes

Mean Total Redness Score

Time frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC

Data from ClinicalTrials.gov

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