Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02565173
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.




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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565173


Locations
Layout table for location information
United States, Massachusetts
Inotek Pharmaceuticals Corporation
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation
Investigators
Layout table for investigator information
Study Director: Cadmus C Rich, MD,MBA,CPE Inotek Pharmaceuticals Corp.
Layout table for additonal information
Responsible Party: Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02565173    
Other Study ID Numbers: IPC-01-2015
First Posted: October 1, 2015    Key Record Dates
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:
Layout table for 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