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

• ClinicalTrials.gov Identifier: NCT02565173
• Recruitment Status: Completed
• First Posted: October 1, 2015
• Last Update Posted: December 6, 2016
• Sponsor: Inotek Pharmaceuticals Corporation
• Information provided by (Responsible Party): Inotek Pharmaceuticals Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)	Drug: trabodenoson 4.5% BID; Drug: trabodenoson 6.0% QD; Drug: trabodenoson 3.0% QD; Drug: timolol 0.5% BID; Drug: placebo BID	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 303 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
• Study Start Date: September 2015
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: Timoptic
Placebo Comparator: placebo BID; placebo Ophthalmic Formulation	Drug: placebo BID; Placebo administered twice per day in both eyes for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. Mean Intraocular Pressure (IOP) [ Time Frame: Three Months ]

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Inotek Pharmaceuticals Corporation

Lexington, Massachusetts, United States, 02421

Sponsors and Collaborators

Inotek Pharmaceuticals Corporation

Investigators

• Study Director: Cadmus C Rich, MD,MBA,CPE; Inotek Pharmaceuticals Corp.

More Information

• Responsible Party: Inotek Pharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT02565173
• Other Study ID Numbers: IPC-01-2015
• First Posted: October 1, 2015
• Last Update Posted: December 6, 2016
• Last Verified: December 2016

Keywords provided by Inotek Pharmaceuticals Corporation:

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

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Adenosine; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Vasodilator Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Purinergic Agents