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

Alcon

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine 0.1% Vehicle; Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%; Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%; Drug: Olopatadine 0.2% Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987272

C-09-044

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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267 participants in 2 patient groups

Pataday+Pataday Vehicle

Experimental group

Description:

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

Treatment:

Drug: Olopatadine 0.2% Vehicle

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Patanol+Patanol Vehicle

Active Comparator group

Description:

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

Treatment:

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%

Drug: Olopatadine 0.1% Vehicle