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Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

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.
 
ClinicalTrials.gov Identifier: NCT00331500
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
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
Actual Study Start Date : April 18, 2006
Actual Primary Completion Date : July 27, 2006
Actual Study Completion Date : July 27, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
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
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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
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Study Director: Alcon, A Novartis Company Alcon, a Novartis Company
More Information
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Publications of Results:
https://www.ncbi.nlm.nih.gov/pubmed/23379201

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00331500    
Other Study ID Numbers: C-04-60
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: June 2008
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine Hydrochloride
Pharmaceutical Solutions
Ophthalmic Solutions
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