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

Ocular Hypertension (OHT) Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT01917383
• Study type: Interventional
• Source: Inotek Pharmaceuticals Corporation
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Completion date: September 2014