Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 2
- Intervention
- AL-39256 Ophthalmic Suspension, 1%
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Alcon Research
- Enrollment
- 104
- Primary Endpoint
- Mean change from baseline in IOP
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
AL-39256
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.
Intervention: AL-39256 Ophthalmic Suspension, 1%
XALATAN
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.
Intervention: Latanoprost Ophthalmic Solution, 0.005%
XALATAN
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.
Intervention: 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.
Intervention: Vehicle
Outcomes
Primary Outcomes
Mean change from baseline in IOP
Time Frame: Week 4