Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02565173

Acronym

MATrX-1

Enrollment

303

Registered

2015-10-01

Start date

2015-09-30

Completion date

2016-11-30

Last updated

2016-12-06

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

Conditions

Ocular Hypertension (OHT), Primary Open-Angle Glaucoma (POAG)

Keywords

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

Brief summary

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.

Interventions

DRUGtrabodenoson 4.5% BID

Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.

DRUGtrabodenoson 6.0% QD

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.

DRUGtrabodenoson 3.0% QD

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.

DRUGtimolol 0.5% BID

Timolol 0.5% administered twice per day in both eyes for 12 weeks.

DRUGplacebo BID

Placebo administered twice per day in both eyes for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean Intraocular Pressure (IOP)	Three Months

Other

Measure	Time frame
Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety.	Through Study Completion, up to 13 weeks.

Countries

United States

Outcome results

None listed

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