Ocular Hypertension (OHT), Primary Open-Angle Glaucoma (POAG)
Conditions
Keywords
glaucoma, primary open angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
Brief summary
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
Criteria Inclusion Criteria: 1. Subject has signed and dated the current informed consent form (ICF). 2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). 3. Aged 18 or older. 4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg. Exclusion Criteria: 1. No significant visual field loss or any new field loss within the past year. 2. Cup-to-disc ratio ≥0.8 3. Central corneal thickness \<500 µm or \>600 µm 4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Interventions
Ophthalmic eye drop
Ophthalmic eye drop
Ophthalmic eye drop
Sponsors
Study design
Eligibility
Inclusion criteria
1. Subject has signed and dated the current informed consent form (ICF). 2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). 3. Aged 18 or older. 4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
Exclusion criteria
1. No significant visual field loss or any new field loss within the past year. 2. Cup-to-disc ratio ≥0.8 3. Central corneal thickness \<500 µm or \>600 µm 4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) | 12 weeks |
Countries
United States