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Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00331500
First Posted: May 31, 2006
Last Update Posted: August 14, 2017
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 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 Hydrochloride Ophthalmic Solution, 0.2% Drug: Olopatadine Hydrochloride Ophthalmic Solution 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 Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Daily ocular itching and redness scores [ Time Frame: Up to Day 14 ]

Secondary Outcome Measures:
  • Percentage of patients with daily ocular itching and redness scores of 0 [ Time Frame: Up to Day 14 ]

Enrollment: 287
Actual Study Start Date: April 18, 2006
Study Completion Date: July 27, 2006
Primary Completion Date: July 27, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine Hydrochloride 0.2%
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Placebo Comparator: Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks
Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle
Inactive ingredients used as a placebo comparator

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT00331500


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Alcon, A Novartis Company Alcon, a Novartis Company
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00331500     History of Changes
Other Study ID Numbers: C-04-60
First Submitted: May 30, 2006
First Posted: May 31, 2006
Last Update Posted: August 14, 2017
Last Verified: June 2008

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