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

Inotek Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension (OHT); Primary Open-Angle Glaucoma (POAG)

Treatments: Drug: trabodenoson 6.0% QD; Drug: placebo BID; Drug: timolol 0.5% BID; Drug: trabodenoson 4.5% BID; Drug: trabodenoson 3.0% QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02565173

IPC-01-2015

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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303 participants in 5 patient groups, including a placebo group

trabodenoson 4.5% BID

Experimental group

Description:

trabodenoson 4.5% Ophthalmic Formulation

Treatment:

Drug: trabodenoson 4.5% BID

trabodenoson 6.0% QD

Experimental group

Description:

trabodenoson 6.0% Ophthalmic Formulation

Treatment:

Drug: trabodenoson 6.0% QD

trabodenoson 3.0% QD

Experimental group

Description:

trabodenoson 3.0% Ophthalmic Formulation

Treatment:

Drug: trabodenoson 3.0% QD

timolol 0.5% BID

Active Comparator group

Description:

timolol 0.5% Ophthalmic Formulation

Treatment:

Drug: timolol 0.5% BID

placebo BID

Placebo Comparator group

Description:

placebo Ophthalmic Formulation

Treatment:

Drug: placebo BID