AGN-229666 for the Treatment of Allergic Conjunctivitis

Allergan

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: AGN-229666; Other: vehicle of AGN-229666

Study type: Interventional

Funder types: Industry

Identifiers

NCT01754766

229666-002

Details and patient eligibility

About

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients living in Japan with a history of allergic conjunctivitis
• Willing to discontinue wearing contact lenses during the study period

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

AGN-229666 Dose A

Experimental group

Description:

One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.

Treatment:

Drug: AGN-229666

AGN-229666 Dose B

Experimental group

Description:

One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.

Treatment:

Drug: AGN-229666

vehicle of AGN-229666

Placebo Comparator group

Description:

One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Treatment:

Other: vehicle of AGN-229666