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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987272
Other study ID # C-09-044
Secondary ID
Status Completed
Phase Phase 3
First received September 28, 2009
Last updated July 28, 2014
Start date October 2009
Est. completion date November 2009

Study information

Verified date July 2014
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%

Olopatadine 0.2% Vehicle
Inactive ingredients used as placebo comparator
Olopatadine 0.1% Vehicle
Inactive ingredients used as placebo comparator

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Ocular Itching Score Day 0 of treatment: 3, 5, and 10 minutes post CAC No
Secondary Mean Total Redness Score Day 0 of treatment: 3, 10, 20 minutes post-CAC No
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