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Completed

NCT Number: NCT02565173

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inotek Pharmaceuticals Corporation

Lexington, Massachusetts, 02421, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trabodenoson 4.5% BID

Drug

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

Other names: INO-8875

trabodenoson 6.0% QD

Drug

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

trabodenoson 3.0% QD

Drug

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

timolol 0.5% BID

Drug

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

Other names: Timoptic

placebo bid

Drug

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

Primary outcomes

  1. Mean Intraocular Pressure (IOP)

    Time frame: Three Months

Other outcomes

  1. Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety.

    Time frame: Through Study Completion, up to 13 weeks.

Sponsors and collaborators

Lead sponsor

Inotek Pharmaceuticals Corporation

Industry

Registry information

Official study 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

Acronym: MATrX-1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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