Ocular Hypertension (OHT) Clinical Trial
Official title:
Phase II, Randomized, Double-masked, Active-controlled Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Subjects With Ocular Hypertension or Primary Open-Angle Glaucoma
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.
This is a phase II, randomized, double-masked study to evaluate the efficacy and tolerability
of topical ocular delivery of fixed-dose combinations of trabodenoson and latanoprost in
subjects with OHT or POAG.
The Primary Objective of this Trial is to evaluate the efficacy of different topical ocular
doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop
daily to both eyes over two consecutive 4 week periods. The Secondary Objective is to
evaluate the tolerability and safety of different doses of trabodenoson (3.0% and 6.0%) when
added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4
week periods. the Hypotheses is that topical ocular co-administration of 3.0% or 6.0%
trabodenoson plus latanoprost 0.0025% or 0.005% ophthalmic formulation will reduce IOP and be
well-tolerated.
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 (vehicle control matched to trabodenoson) 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 manner that is masked to the patient. The Treatment Period will be followed by
an Observation Period of approximately 7 days wherein no study eye drops are instilled.
To mimic what is generally seen in clinical trials, the number of subjects with ocular
hypertension as their diagnosis will be limited to approximately 30% of the total subjects
enrolled. Additionally, so the trial mirrors the general population demographics (so as to
improve generalizability of the results) the proportion of African American subjects will be
approximately 25% or less but not less than 12% of the total subjects enrolled.
The purpose of the study is to assess the efficacy, tolerability, and safety of binocular
topical application of different doses of trabodenoson (3.0% and 6.0%) when added to
latanoprost (0.005% or 0.0025%) one drop daily over two consecutive 4 week periods in
subjects with POAG or OHT. Data collection will include efficacy (masked-IOPs), local
(ophthalmic) and systemic tolerability and safety assessments
;
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