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Completed

NCT Number: NCT01754766

AGN-229666 for the Treatment of Allergic Conjunctivitis

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

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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 2

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
  • Willing to discontinue wearing contact lenses during the study period

Exclusion criteria

  • Use of nicotine products during the study period
  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an ocular herpetic infection
  • Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months

Treatment and study plan

AGN-229666

Drug

One drop of AGN-229666 into each eye on Day 1 and Day 15.

vehicle of AGN-229666

Other

One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Primary outcomes

  1. Ocular Itching Score at Day 1

    Time frame: Day 1

    The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

Secondary outcomes

  1. Ocular Itching Score at Day 15

    Time frame: Day 15

    The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

  2. Conjunctival Hyperemia Score

    Time frame: Day 1

    Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2012
Registry last updated
Feb 4, 2014

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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