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

Phase 2

Completed

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: Vehicle; Drug: AL-39256 Ophthalmic Suspension, 1%; Drug: Latanoprost Ophthalmic Solution, 0.005%

• Registration Number: NCT00761709
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Study Start: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-10
• Disposition First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-11
• Disposition First Posted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	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.
XALATAN	Vehicle	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.
AL-39256	AL-39256 Ophthalmic Suspension, 1%	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.
XALATAN	Latanoprost Ophthalmic Solution, 0.005%	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.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in IOP	Week 4