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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014