Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inotek Pharmaceuticals Corporation
• Treatments: Adenosine; Timolol

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