Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
Status:
Completed
Trial end date:
2017-05-31
Target enrollment:
Participant gender:
Summary
Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of
topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in
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 (if washout is needed), including their routine
glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to
both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes
for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing
in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active
drug product. During the Treatment Period, study drug (Active and Placebo) eye drop
applications will occur twice daily, in the morning and in the evening. The Treatment Period
will be 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 overall benefit/risk profile of binocular topical
application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost
(0.005% or 0.0025%) one drop daily (QD) for 8 weeks.