AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Allergan

Status and phase: Completed; Phase 3

Conditions: Conjunctivitis, Allergic

Treatments: Drug: AGN-229666; Drug: Olopatadine; Drug: Vehicle to AGN-229666

Study type: Interventional

Funder types: Industry

Identifiers

NCT02161146

229666-006

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 5 patient groups, including a placebo group

AGN-229666

Experimental group

Description:

One drop of AGN-229666 in each eye on Days 1 and 15.

Treatment:

Drug: AGN-229666

Vehicle

Placebo Comparator group

Description:

One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.

Treatment:

Drug: Vehicle to AGN-229666

Olopatadine

Active Comparator group

Description:

One drop of olopatadine in each eye on Days 1 and 15.

Treatment:

Drug: Olopatadine

AGN-229666/Olopatadine

Other group

Description:

One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.

Treatment:

Drug: AGN-229666

Drug: Olopatadine

AGN-229666/Vehicle

Other group

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.

Treatment:

Drug: AGN-229666

Drug: Vehicle to AGN-229666