Formulation Comparison in Normal Volunteers

Aerie Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Normal Volunteers

Treatments: Drug: AR-12286

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250197

AR-12286-CS101

Details and patient eligibility

About

This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.

Full description

Not desired.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal volunteers

Exclusion criteria

• Active ophthalmic or systemic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Formulation A

Experimental group

Description:

AR-12286 Ophthalmic Solution Formulation A

Treatment:

Drug: AR-12286

Formulation B

Experimental group

Description:

AR-12286 Ophthalmic Solution Formulation B

Treatment:

Drug: AR-12286