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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987272
• Other study ID #: C-09-044
• 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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

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