Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00331500

Purpose

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: olopatadine 0.2%	Phase III

Drug Information available for: Olopatadine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Daily signs and symptoms scores during the 14 days of peak pollen

Secondary Outcome Measures:

Patients with daily signs and symptoms scores of zero during the 14 days of peak pollen

Estimated Enrollment:	250
Study Start Date:	August 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria:

Under 10 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331500

Locations

United States, Texas
Alcon Research, Ltd.
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Stella Robertson

Study Director

More Information

Study ID Numbers:	C-04-60
Study First Received:	May 30, 2006
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00331500
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate
Histamine phosphate

Conjunctivitis
Olopatadine
Conjunctival Diseases
Histamine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents
Pharmacologic Actions
Histamine Antagonists
Sensory System Agents

Analgesics, Non-Narcotic
Therapeutic Uses
Histamine H1 Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009