Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma (MATrX-1)

Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

glaucoma, primary open-angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork

Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Inclusion Criteria: Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) Mean Intraocular pressure (IOP) of ≥24 and ≤34 Exclusion Criteria: Significant visual field loss or any new field loss within the past year Cup-to-disc ratio >0.8 Central corneal thickness <490 µm or >610 µm A recent (acute) or chronic medical condition that might obfuscate the Subject's study data