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

NCT02082262 | Completed Phase 3 Results

• 1 other identifier: 229666-005
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Conjunctivitis, Allergic

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Day 70

Study Arms (1)

AGN-229666

EXPERIMENTAL

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

Drug: AGN-229666

Interventions

AGN-229666 DRUG

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

AGN-229666

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: October 8, 2015

Record last verified: 2016-02

Locations

JP (1)