Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Overview
- Phase
- Phase 2
- Intervention
- AL-12182 0.003% Ophthalmic Solution
- Conditions
- Open-angle Glaucoma
- Sponsor
- Alcon Research
- Enrollment
- 118
- Primary Endpoint
- Mean Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older.
- •Diagnosis of open-angle glaucoma or ocular hypertension.
- •LogMAR visual acuity not worse than 0.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Clinically relevant ophthalmic or systemic conditions.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
AL-12182 0.003%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention: AL-12182 0.003% Ophthalmic Solution
AL-12182 Solution Vehicle
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention: AL-12182 Ophthalmic Solution Vehicle
Latanoprost
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention: Latanoprost 0.005% Ophthalmic Solution
AL-12182 0.01%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention: AL-12182 0.01% Ophthalmic Solution
AL-12182 0.03%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention: AL-12182 0.03% Ophthalmic Solution
Outcomes
Primary Outcomes
Mean Intraocular Pressure (IOP)