- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00987272
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
July 28, 2014 updated by: Alcon Research
A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
267
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
|
Other Names:
Inactive ingredients used as placebo comparator
|
Active Comparator: Patanol+Patanol Vehicle
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
|
Other Names:
Inactive ingredients used as placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Ocular Itching Score
Time Frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC
|
Day 0 of treatment: 3, 5, and 10 minutes post CAC
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Total Redness Score
Time Frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC
|
Day 0 of treatment: 3, 10, 20 minutes post-CAC
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pamela Smith, BS, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 28, 2009
First Submitted That Met QC Criteria
September 29, 2009
First Posted (Estimate)
September 30, 2009
Study Record Updates
Last Update Posted (Estimate)
July 31, 2014
Last Update Submitted That Met QC Criteria
July 28, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Olopatadine Hydrochloride
Other Study ID Numbers
- C-09-044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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