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

NCT02565173 — Phase 3, Completed, 303 participants, Inotek Pharmaceuticals Corporation

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02565173, acronym MATrX-1
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	303 (Actual)
Sponsor	Inotek Pharmaceuticals Corporation (Industry)
Conditions	Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Interventions	trabodenoson 4.5% BID, trabodenoson 6.0% QD, trabodenoson 3.0% QD, timolol 0.5% BID, placebo BID (Drug)
Dates	start 2015-09-01, primary completion 2016-11-01, completion 2016-11-01, first posted 2015-10-01, last updated 2016-12-06
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
trabodenoson 4.5% BID	Experimental	Drug: trabodenoson 4.5% BID	trabodenoson 4.5% Ophthalmic Formulation
trabodenoson 6.0% QD	Experimental	Drug: trabodenoson 6.0% QD	trabodenoson 6.0% Ophthalmic Formulation
trabodenoson 3.0% QD	Experimental	Drug: trabodenoson 3.0% QD	trabodenoson 3.0% Ophthalmic Formulation
timolol 0.5% BID	Active comparator	Drug: timolol 0.5% BID	timolol 0.5% Ophthalmic Formulation
placebo BID	Placebo comparator	Drug: placebo BID	placebo Ophthalmic Formulation

trabodenoson 4.5% BID (Drug), also known as INO-8875: Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
trabodenoson 6.0% QD (Drug), also known as INO-8875: 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% QD (Drug), also known as INO-8875: 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.
timolol 0.5% BID (Drug), also known as Timoptic: Timolol 0.5% administered twice per day in both eyes for 12 weeks.
placebo BID (Drug): Placebo administered twice per day in both eyes for 12 weeks.

+Outcome measures

Primary outcomes

Mean Intraocular Pressure (IOP) [Three Months]

Other outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Inotek Pharmaceuticals Corporation	Lexington, Massachusetts	United States

+Investigators

Cadmus C Rich, MD,MBA,CPE, Study director, Inotek Pharmaceuticals Corp.