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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension (OHT); Primary Open-Angle Glaucoma (POAG)
• Intervention / Treatment: Drug: trabodenoson 4.5% BID; Drug: trabodenoson 6.0% QD; Drug: trabodenoson 3.0% QD; Drug: timolol 0.5% BID; Drug: placebo BID

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Inotek Pharmaceuticals Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trabodenoson 4.5% BID; trabodenoson 4.5% Ophthalmic Formulation	Drug: trabodenoson 4.5% BID; Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.; Other Names: INO-8875
Experimental: trabodenoson 6.0% QD; trabodenoson 6.0% Ophthalmic Formulation	Drug: trabodenoson 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.; Other Names: INO-8875
Experimental: trabodenoson 3.0% QD; trabodenoson 3.0% Ophthalmic Formulation	Drug: trabodenoson 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.; Other Names: INO-8875
Active Comparator: timolol 0.5% BID; timolol 0.5% Ophthalmic Formulation	Drug: timolol 0.5% BID; Timolol 0.5% administered twice per day in both eyes for 12 weeks.; Other Names: Timoptic
Placebo Comparator: placebo BID; placebo Ophthalmic Formulation	Drug: placebo BID; Placebo administered twice per day in both eyes for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Intraocular Pressure (IOP)	Three Months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inotek Pharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: ocular hypertension; glaucoma; primary open-angle glaucoma; adenosine agonist; eye drop; trabodenoson; trabecular meshwork
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Timolol; Adenosine
• Other Study ID Numbers: IPC-01-2015