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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug); Olopatadine Hydrochloride Ophthalmic Solution, 0.1% (Drug); Olopatadine 0.2% Vehicle (Drug); Olopatadine 0.1% Vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Pamela Smith, BS, Study Director, Affiliation: Alcon Research


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.

Clinical Details

Official title: A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Ocular Itching Score

Secondary outcome: Mean Total Redness Score


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: October 2009
Last updated: July 28, 2014

Page last updated: August 23, 2015

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