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

Phase 3

Completed

• Conditions: Conjunctivitis, Allergic
• Interventions: Drug: AGN-229666

• Registration Number: NCT02082262
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-09-08
• Results First Submitted QC: 2015-09-08
• Results First Posted: 2015-10-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale	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.