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Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan

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: NCT02251613
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : February 9, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine HCl ophthalmic solution, 0.1% Drug: Epinastine HCl ophthalmic solution, 0.05% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Olopatadine (right or left, randomized)
Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
Drug: Olopatadine HCl ophthalmic solution, 0.1%
Other Name: PATANOL®

Active Comparator: Epinastine (fellow eye)
Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
Drug: Epinastine HCl ophthalmic solution, 0.05%



Primary Outcome Measures :
  1. Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 [ Time Frame: Day 1, 7 minutes post-CAC ]
    A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).


Secondary Outcome Measures :
  1. Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 [ Time Frame: Day 1, 20 minutes post-CAC ]
    A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be Japanese and live in Japan;
  • History of allergic conjunctivitis;
  • Positive skin test reaction to Japanese cedar at Visit 1;
  • Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
  • Able and willing to avoid all disallowed medications during the specified period;
  • Able to discontinue wearing contact lenses during the specified period;
  • Sign Informed Consent;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History of hypersensitivity to the study drug or compounds;
  • Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
  • Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
  • Presence of active ocular infection;
  • Use of disallowed medications as specified in the protocol;
  • Pregnant, nursing, or planning to become pregnant during the study;
  • Other protocol-defined exclusion criteria may apply.

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): NCT02251613


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Tsunemitsu Senta Alcon Japan, Ltd.

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02251613    
Other Study ID Numbers: 13-100-0009
UMIN000013943 ( Registry Identifier: UMIN )
First Posted: September 29, 2014    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine Hydrochloride
Ophthalmic Solutions
Pharmaceutical Solutions
Epinastine
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