Ocular Hypotensive Efficacy of AR-102

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Glaucoma

Treatments: Drug: AR-102 0.03% Ophthalmic Solution; Drug: AR-102 0.005% Ophthalmic Solution; Drug: AR-102 0.01% Ophthalmic Solution; Drug: AR-102 0.003% Ophthalmic Solution; Drug: AR-102 Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523250

AR102-CS201

Details and patient eligibility

About

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

Full description

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or greater (male, or female not of childbearing potential).
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
• Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better

Exclusion criteria

• Known hypersensitivity to any component of the formulation or to topical anesthetics
• Previous glaucoma intraocular surgery or laser procedures in study eye(s)
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
• Participation in any study involving an investigational drug within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

82 participants in 5 patient groups

AR-102 0.003% Ophthalmic Solution

Experimental group

Description:

q.d. ocular

Treatment:

Drug: AR-102 0.003% Ophthalmic Solution

AR-102 0.005% Ophthalmic Solution

Experimental group

Description:

q.d. ocular

Treatment:

Drug: AR-102 0.005% Ophthalmic Solution

AR-102 0.01% Ophthalmic Solution

Experimental group

Description:

q.d. ocular

Treatment:

Drug: AR-102 0.01% Ophthalmic Solution

AR-102 0.03% Ophthalmic Solution

Experimental group

Description:

q.d. ocular

Treatment:

Drug: AR-102 0.03% Ophthalmic Solution

AR-102 Vehicle Ophthalmic Solution

Experimental group

Description:

q.d. ocular

Treatment:

Drug: AR-102 Vehicle Ophthalmic Solution