Back to resultsAGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Primary Purpose
Conjunctivitis, Allergic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AGN-229666
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis, Allergic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AGN-229666
Arm Description
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082262
Brief Title
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Allergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-229666
Arm Type
Experimental
Arm Description
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-229666
Intervention Description
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Description
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.
Time Frame
Baseline, Day 70
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
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