Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
NCT00987272 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267
Last updated 2014-07-31
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.
Conditions
- Allergic Conjunctivitis
Interventions
- DRUG
-
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
- DRUG
-
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
- DRUG
-
Olopatadine 0.2% Vehicle
Inactive ingredients used as placebo comparator
- DRUG
-
Olopatadine 0.1% Vehicle
Inactive ingredients used as placebo comparator
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Pamela Smith, BS · Alcon Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
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