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Completed

NCT Number: NCT02161146

AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion criteria

  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an eye herpetic infection.

Treatment and study plan

AGN-229666

Drug

One drop of AGN-229666 in the eye on Days 1 and 15.

Vehicle to AGN-229666

Drug

One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Olopatadine

Drug

One drop of olopatadine in the eye on Days 1 and 15.

Other names: Patanol®

Primary outcomes

  1. Ocular Itching Score

    Time frame: Days 1 and 15

    Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.

Secondary outcomes

  1. Conjunctival Hyperemia Score

    Time frame: Days 1 and 15

    Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2014
Registry last updated
Apr 17, 2019

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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