NCT01917383

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Inotek Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Open-Angle Glaucoma (POAG)
• Ocular Hypertension (OHT)

Interventions

Type	Name	Description
DRUG	Trabodenoson	Ophthalmic eye drop
DRUG	Latanoprost	Ophthalmic eye drop
DRUG	Timolol	Ophthalmic eye drop

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-08-06
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States