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