Primary Open Angle Glaucoma (POAG) Clinical Trial
Official title:
A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety and Tolerability of Latanoprost Sustained Release (SR) Insert in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. The first cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus achieving twice the drug levels compared to cohort I and third cohort will receive high dose drug insert.
The purpose of this study is to determine the tolerability and safety of the biodegradable
extended release Latanoprost subconjunctival insert for primary open angle glaucoma (POAG)
and ocular hypertension (OHT) patients. Intraocular pressure lowering ability of
biodegradable extended release Latanoprost subconjunctival insert in POAG and OHT patients
will also be evaluated.
Low dose inserts have an initial release rate of approximately 1 µg/day slowing to 0.2
µg/day after approximately 10 days; this release rate is maintained. High dose inserts have
an initial release of approximately 4 µg/day, which slows to approximately 1 ug/day after 10
days. Each drop of Xalatan (the commercial form of latanoprost) contains approximately 1 µg
of latanoprost. The first cohort will receive inserts that initially provide the same dose
as is administered topically before their release rate slows down to a lower dose. The
inserts used in this study are composed of a drug core in a (Poly Lactic Glycolic acid) PLGA
polymer tube. One end of the tube is capped with an impermeable polymer (silicone) and the
other end with a permeable polymer (Polyvinyl alcohol). Drug release occurs across the
permeable end and is a function of internal diameter of the tube. Low dose insert and high
dose insert are exactly the same except that for low dose inserts the internal diameter of
the PLGA tubes is smaller. Thus different release rates (and drug loading) are obtained with
the same formulation. Inserts are designed to provide steady state release for 3-6 months.
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Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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