AGN-229666 for the Treatment of Allergic Conjunctivitis
1 other identifier
interventional
90
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 4, 2014
CompletedFebruary 4, 2014
December 1, 2013
3 months
December 19, 2012
December 17, 2013
December 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Ocular Itching Score at Day 1
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
Day 1
Secondary Outcomes (2)
Ocular Itching Score at Day 15
Day 15
Conjunctival Hyperemia Score
Day 1
Study Arms (3)
AGN-229666 Dose A
EXPERIMENTALOne drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
AGN-229666 Dose B
EXPERIMENTALOne drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
vehicle of AGN-229666
PLACEBO COMPARATOROne drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Interventions
One drop of AGN-229666 into each eye on Day 1 and Day 15.
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Eligibility Criteria
You may qualify if:
- Japanese patients living in Japan with a history of allergic conjunctivitis
- Willing to discontinue wearing contact lenses during the study period
You may not qualify if:
- Use of nicotine products during the study period
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an ocular herpetic infection
- Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 21, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
February 4, 2014
Results First Posted
February 4, 2014
Record last verified: 2013-12