Expired Study
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Lexington, Massachusetts 02421


Purpose:

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.


Criteria:

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


NCT ID:

NCT02565173


Primary Contact:

Study Director
Cadmus C Rich, MD,MBA,CPE
Inotek Pharmaceuticals Corp.


Backup Contact:

N/A


Location Contact:

Lexington, Massachusetts 02421
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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