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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987272

Enrollment

267

Registered

2009-09-30

Start date

2009-10-31

Completion date

2009-11-30

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Keywords

Allergies, Ocular

Brief summary

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.

Interventions

DRUGOlopatadine Hydrochloride Ophthalmic Solution, 0.2%

DRUGOlopatadine Hydrochloride Ophthalmic Solution, 0.1%

DRUGOlopatadine 0.2% Vehicle

Inactive ingredients used as placebo comparator

DRUGOlopatadine 0.1% Vehicle

Inactive ingredients used as placebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean Ocular Itching Score	Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary

Measure	Time frame
Mean Total Redness Score	Day 0 of treatment: 3, 10, 20 minutes post-CAC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026