NCT02565173

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

Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Inotek Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-Angle Glaucoma (POAG)
• Ocular Hypertension (OHT)

Interventions

Type	Name	Description
DRUG	trabodenoson 4.5% BID	Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
DRUG	trabodenoson 6.0% QD	Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
DRUG	trabodenoson 3.0% QD	Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
DRUG	timolol 0.5% BID	Timolol 0.5% administered twice per day in both eyes for 12 weeks.
DRUG	placebo BID	Placebo administered twice per day in both eyes for 12 weeks.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-10-01
• Last updated: 2016-12-06

Locations

1 site across 1 country: United States