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

Phase 2

Terminated

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: AL-59412C injectable solution; Drug: Travoprost injectable solution; Drug: AL-59412C Vehicle

• Registration Number: NCT01312454
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Study Start: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-26
• Disposition First Submitted QC: 2013-09-26
• Last Update Submitted: 2013-09-26
• Disposition First Posted: 2013-10-25
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-59412C Concentration 2	AL-59412C injectable solution	AL-59412C injectable solution, single intravitreal injection
Travoprost	Travoprost injectable solution	Travoprost injectable solution, single intravitreal injection
AL-59412C Concentration 1	AL-59412C injectable solution	AL-59412C injectable solution, single intravitreal injection
Vehicle	AL-59412C Vehicle	AL-59412C Vehicle, single intravitreal injection

Primary Outcome Measures

Name	Time	Method
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection	Time to event, up to 24 hours post-injection	IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.