AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

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

Completed

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Key information

Conditions

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

Age range

10 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 allergic conjunctivitis with itching and redness
Able and willing to discontinue wearing any contact lenses during the study period.

Exclusion criteria

Eye surgical intervention and/or a history of refractive surgery within 6 months
History of retinal detachment, diabetic retinopathy, or progressive retinal disease
Presence of active eye infection (bacterial, viral, or fungal)
History of an eye herpetic infection
Use of corticosteroids within 6 months or anticipated use during the study.

Treatment and study plan

AGN-229666

Drug

One to two drops of AGN-229666 twice daily in each eye for 10 weeks.

Primary outcomes

Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale

Time frame: Baseline, Day 70

Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 10, 2014
Registry last updated: Mar 14, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed