Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: AL-39256 Ophthalmic Suspension, 1%; Drug: Vehicle; Drug: Latanoprost Ophthalmic Solution, 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761709

C-08-28

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with open-angle glaucoma or ocular hypertension.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Females of childbearing potential.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

104 participants in 3 patient groups, including a placebo group

AL-39256

Experimental group

Description:

AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Treatment:

Drug: AL-39256 Ophthalmic Suspension, 1%

XALATAN

Active Comparator group

Description:

Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.

Treatment:

Drug: Latanoprost Ophthalmic Solution, 0.005%

Drug: Vehicle

Vehicle

Placebo Comparator group

Description:

Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Treatment:

Drug: Vehicle