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

Alcon

Status and phase: Terminated; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: AL-59412C injectable solution; Drug: AL-59412C Vehicle; Drug: Travoprost injectable solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312454

C-10-038

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 4 patient groups, including a placebo group

AL-59412C Concentration 1

Experimental group

Description:

AL-59412C injectable solution, single intravitreal injection

Treatment:

Drug: AL-59412C injectable solution

AL-59412C Concentration 2

Experimental group

Description:

AL-59412C injectable solution, single intravitreal injection

Treatment:

Drug: AL-59412C injectable solution

Travoprost

Active Comparator group

Description:

Travoprost injectable solution, single intravitreal injection

Treatment:

Drug: Travoprost injectable solution

Vehicle

Placebo Comparator group

Description:

AL-59412C Vehicle, single intravitreal injection

Treatment:

Drug: AL-59412C Vehicle