Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

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

Intervention / Treatment
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* Drug: trabodenoson 4.5% BID
* Drug: trabodenoson 6.0% QD
* Drug: trabodenoson 3.0% QD
* Drug: timolol 0.5% BID
* Drug: placebo BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, primary open-angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork