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

Completed · Phase 2

Conditions studied: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)

In brief

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).

Key facts

Study ID

NCT01917383

Run by

Inotek Pharmaceuticals Corporation

People needed

101

Starts

2013-08-01

Expected to finish

2014-09-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Chiltern — Bristol, Tennessee, United States

Full record on ClinicalTrials.gov

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