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

Conjunctivitis, Allergic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082262
• Other study ID #: 229666-005
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2014
• Last updated: February 11, 2016
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No