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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312454

Enrollment

Registered

2011-03-10

Start date

2011-06-30

Completion date

2012-01-31

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-angle Glaucoma

Keywords

intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension

Brief summary

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

Interventions

DRUGAL-59412C injectable solution

Concentration 1 and Concentration 2

DRUGTravoprost injectable solution

DRUGAL-59412C Vehicle

Inactive ingredients used as placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026