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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987272
First Posted: September 30, 2009
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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.

Condition Intervention Phase
Allergic Conjunctivitis Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1% Drug: Olopatadine 0.2% Vehicle Drug: Olopatadine 0.1% Vehicle Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Ocular Itching Score [ Time Frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC ]

Secondary Outcome Measures:
  • Mean Total Redness Score [ Time Frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC ]

Enrollment: 267
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Other Name: PATADAY®
Drug: Olopatadine 0.2% Vehicle
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
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
Other Name: PATANOL®
Drug: Olopatadine 0.1% Vehicle
Inactive ingredients used as placebo comparator

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987272


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Pamela Smith, BS Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00987272     History of Changes
Other Study ID Numbers: C-09-044
First Submitted: September 28, 2009
First Posted: September 30, 2009
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Alcon Research:
Allergies
Ocular

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action