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NCT Number: NCT02251613

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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine HCl ophthalmic solution, 0.1%

Drug

Other names: PATANOL®

Epinastine HCl ophthalmic solution, 0.05%

Drug

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2014
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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