Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Pharmaceutical Solutions; Travoprost

Criteria

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma or ocular hypertension.

• Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.

• Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.

• Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.

• Current or recent (within 30 days) use of any drug that may prolong the QT interval.

• Poor vision resulting from advanced glaucoma in the study eye.

• Intraocular surgery within the past 6 months in the study eye.

• Ocular laser surgery within the past 3 months in the study eye.

• Other protocol-defined exclusion criteria may apply.