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: January 11, 2012
Last verified: January 2012
  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 0.2% + Olopatadine 0.2% vehicle
Drug: Olopatadine 0.1% + Olopatadine 0.1% Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Ocular itching [ Time Frame: 8 hours + 15 minutes post dose ] [ Designated as safety issue: Yes ]
  • Total redness [ Time Frame: 8 hours + 15 minutes post-dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ocular itching [ Time Frame: 4 hours and 8 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 267
Study Start Date: September 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine 0.2% + Olopatadine 0.2% Vehicle
Pataday + Pataday Vehicle
Drug: Olopatadine 0.2% + Olopatadine 0.2% vehicle
Olopatadine 0.2% 1 drop in one eye and its vehicle in the contralateral eye 8 hours before CAC
Active Comparator: Olopatadine 0.1% + Olopatadine 0.1% Vehicle
Patanol + Patanol Vehicle
Drug: Olopatadine 0.1% + Olopatadine 0.1% Vehicle
Olopatadine 0.1% 1 drop in one eye and its vehicle in the contralateral eye 8 hours before CAC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18 years of age or older, either sex, Japanese ethnicity
  • Seasonal Allergic Conjunctivitis--asymptomatic.

Exclusion Criteria:

  • Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (> 1 for redness in any of the three vessels beds—conjuctival, episcleral, ciliary—or itching > 0) at the start of any visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987272

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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: January 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Allergies - Ocular

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

ClinicalTrials.gov processed this record on April 17, 2014