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
Overview
- Phase
- Phase 2
- Intervention
- Trabodenoson
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Sponsor
- Inotek Pharmaceuticals Corporation
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility 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
Arms & Interventions
Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Intervention: Trabodenoson
Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Intervention: Latanoprost
Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Intervention: Latanoprost
Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Intervention: Timolol
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 12 weeks