Back to resultsAGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Primary Purpose
Conjunctivitis, Allergic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AGN-229666
Vehicle to AGN-229666
Olopatadine
Sponsored by
About this trial
This is an interventional prevention trial for Conjunctivitis, Allergic
Eligibility Criteria
Inclusion Criteria:
-Japanese patients living in Japan with a history of allergic conjunctivitis.
Exclusion Criteria:
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an eye herpetic infection.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Active Comparator
Other
Other
Arm Label
AGN-229666
Vehicle
Olopatadine
AGN-229666/Olopatadine
AGN-229666/Vehicle
Arm Description
One drop of AGN-229666 in each eye on Days 1 and 15.
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
One drop of olopatadine in each eye on Days 1 and 15.
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Conjunctival Hyperemia Score
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161146
Brief Title
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2014 (Actual)
Primary Completion Date
December 20, 2014 (Actual)
Study Completion Date
December 20, 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 prevention of allergen-mediated 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
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-229666
Arm Type
Experimental
Arm Description
One drop of AGN-229666 in each eye on Days 1 and 15.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
Arm Title
Olopatadine
Arm Type
Active Comparator
Arm Description
One drop of olopatadine in each eye on Days 1 and 15.
Arm Title
AGN-229666/Olopatadine
Arm Type
Other
Arm Description
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
Arm Title
AGN-229666/Vehicle
Arm Type
Other
Arm Description
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
AGN-229666
Intervention Description
One drop of AGN-229666 in the eye on Days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
Vehicle to AGN-229666
Intervention Description
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
Olopatadine
Other Intervention Name(s)
Patanol®
Intervention Description
One drop of olopatadine in the eye on Days 1 and 15.
Primary Outcome Measure Information:
Title
Ocular Itching Score
Description
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.
Time Frame
Days 1 and 15
Secondary Outcome Measure Information:
Title
Conjunctival Hyperemia Score
Description
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.
Time Frame
Days 1 and 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Japanese patients living in Japan with a history of allergic conjunctivitis.
Exclusion Criteria:
Presence of active eye infection (bacterial, viral, or fungal)
History of an eye herpetic infection.
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
Citations:
PubMed Identifier
29543548
Citation
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.
Results Reference
background
Learn more about this trial
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
We'll reach out to this number within 24 hrs