AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Conjunctivitis, Allergic
• Interventions: Drug: AGN-229666; Drug: Olopatadine; Drug: Vehicle to AGN-229666

• Registration Number: NCT02161146
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-04
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-11
• Primary Completion: 2014-12-20
• Study Completion: 2014-12-20
• Results First Submitted: 2015-12-22
• Results First Submitted QC: 2016-02-08
• Results First Posted: 2016-03-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-229666	AGN-229666	One drop of AGN-229666 in each eye on Days 1 and 15.
AGN-229666/Olopatadine	AGN-229666	One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
AGN-229666/Vehicle	Vehicle to AGN-229666	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.
Vehicle	Vehicle to AGN-229666	One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
AGN-229666/Vehicle	AGN-229666	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.
Olopatadine	Olopatadine	One drop of olopatadine in each eye on Days 1 and 15.
AGN-229666/Olopatadine	Olopatadine	One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.

Primary Outcome Measures

Name	Time	Method
Ocular Itching Score	Days 1 and 15	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

Name	Time	Method
Conjunctival Hyperemia Score	Days 1 and 15	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.