Ocular Hypertension (OHT) Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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