Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
This trial has been completed.
|Conditions||primary open-angle glaucoma (poag), ocular hypertension (oht)|
|Treatments||trabodenoson 4.5% bid, trabodenoson 6.0% qd, trabodenoson 3.0% qd, timolol 0.5% bid, placebo bid|
|Sponsor||Inotek Pharmaceuticals Corporation|
|Start date||September 2015|
|End date||November 2016|
|Trial size||303 participants|
|Trial identifier||NCT02565173, IPC-01-2015|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Mean Intraocular Pressure (IOP)
time frame: Three Months
Male or female participants at least 18 years old.
Inclusion Criteria: - Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) - Mean Intraocular pressure (IOP) of ≥24 and ≤34 Exclusion Criteria: - 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
|Official title||Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma|
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