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

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

Official Title
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A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: AL-59412C injectable solution
* Drug: Travoprost injectable solution
* Drug: AL-59412C Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-59412C Concentration 1<br>AL-59412C injectable solution, single intravitreal injection | Drug: AL-59412C injectable solution<br>* Concentration 1 and Concentration 2<br>|
| Experimental: AL-59412C Concentration 2<br>AL-59412C injectable solution, single intravitreal injection | Drug: AL-59412C injectable solution<br>* Concentration 1 and Concentration 2<br>|
| Active Comparator: Travoprost<br>Travoprost injectable solution, single intravitreal injection | Drug: Travoprost injectable solution<br> <br> |
| Placebo Comparator: Vehicle<br>AL-59412C Vehicle, single intravitreal injection | Drug: AL-59412C Vehicle<br>* Inactive ingredients used as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension