Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
Completed · Phase 3 · Has a placebo group
Conditions studied: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
In brief
Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.
Key facts
- Study ID
- NCT02565173
- Run by
- Inotek Pharmaceuticals Corporation
- People needed
- 303
- Starts
- 2015-09-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2016-12-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
- Mean Intraocular pressure (IOP) of ≥24 and ≤34
You may not qualify if…
- Significant visual field loss or any new field loss within the past year
- Cup-to-disc ratio >0.8
- Central corneal thickness <490 µm or >610 µm
- A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Where it is running
- Inotek Pharmaceuticals Corporation — Lexington, Massachusetts, United States
Full record on ClinicalTrials.gov
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