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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Phase 2
Completed
Conditions
Open-angle Glaucoma
Ocular Hypertension
Interventions
Drug: AL-12182 0.003% Ophthalmic Solution
Other: AL-12182 Ophthalmic Solution Vehicle
Drug: AL-12182 0.01% Ophthalmic Solution
Drug: AL-12182 0.03% Ophthalmic Solution
Registration Number
NCT00069706
Lead Sponsor
Alcon Research
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
118
Inclusion Criteria
  • 18 years or older.
  • Diagnosis of open-angle glaucoma or ocular hypertension.
  • LogMAR visual acuity not worse than 0.6.
  • Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
  • Clinically relevant ophthalmic or systemic conditions.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AL-12182 0.003%AL-12182 0.003% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
AL-12182 Solution VehicleAL-12182 Ophthalmic Solution VehicleOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
LatanoprostLatanoprost 0.005% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
AL-12182 0.01%AL-12182 0.01% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
AL-12182 0.03%AL-12182 0.03% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Primary Outcome Measures
NameTimeMethod
Mean Intraocular Pressure (IOP)
Secondary Outcome Measures
NameTimeMethod
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