A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Detailed Description
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Criteria Inclusion Criteria: Subject has signed and dated the current informed consent form (ICF). Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). Aged 18 or older. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg. Exclusion Criteria: No significant visual field loss or any new field loss within the past year. Cup-to-disc ratio ≥0.8 Central corneal thickness <500 µm or >600 µm A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Official Title
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A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy 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
* Drug: Latanoprost
* Drug: Timolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed and dated the current informed consent form (ICF). Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). Aged 18 or older. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg. Exclusion Criteria: No significant visual field loss or any new field loss within the past year. Cup-to-disc ratio ≥0.8 Central corneal thickness <500 µm or >600 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 Plus Latanoprost<br>Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop | Drug: Trabodenoson<br>* Ophthalmic eye drop<br>* Other names: INO-8875;Drug: Latanoprost<br>* Ophthalmic eye drop<br>* Other names: Xalatan;|
| Active Comparator: Timolol Plus Latanoprost<br>A Beta-blocker eye drop plus a prostaglandin analogue eye drop | Drug: Latanoprost<br>* Ophthalmic eye drop<br>* Other names: Xalatan;Drug: Timolol<br>* Ophthalmic eye drop<br>* Other names: Timoptic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) |  | 12 weeks | 

 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