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:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00987272
First received: September 28, 2009
Last updated: July 28, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Total Redness Score [ Time Frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00987272

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00987272     History of Changes
Other Study ID Numbers: C-09-044
Study First Received: September 28, 2009
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014