AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
1 other identifier
interventional
240
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2014
Shorter than P25 for phase_3
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
June 4, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2014
CompletedResults Posted
Study results publicly available
March 7, 2016
CompletedApril 17, 2019
April 1, 2019
7 months
June 9, 2014
December 22, 2015
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Ocular Itching Score
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
Days 1 and 15
Secondary Outcomes (1)
Conjunctival Hyperemia Score
Days 1 and 15
Study Arms (5)
AGN-229666
EXPERIMENTALOne drop of AGN-229666 in each eye on Days 1 and 15.
Vehicle
PLACEBO COMPARATOROne drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
Olopatadine
ACTIVE COMPARATOROne drop of olopatadine in each eye on Days 1 and 15.
AGN-229666/Olopatadine
OTHEROne drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
AGN-229666/Vehicle
OTHEROne drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Interventions
One drop of AGN-229666 in the eye on Days 1 and 15.
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
One drop of olopatadine in the eye on Days 1 and 15.
Eligibility Criteria
You may qualify if:
- Japanese patients living in Japan with a history of allergic conjunctivitis.
You may not qualify if:
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an eye herpetic infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Tokyo, Japan
Related Publications (1)
Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.
PMID: 29543548BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 11, 2014
Study Start
June 4, 2014
Primary Completion
December 20, 2014
Study Completion
December 20, 2014
Last Updated
April 17, 2019
Results First Posted
March 7, 2016
Record last verified: 2019-04