NCT01180062

Safety Study of Latanoprost Slow Release Insert

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Daniel Moore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Latanoprost	Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost. Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. Duration of drug release is expected to be 3-6 months. Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.
DRUG	Arm 2	Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.
DRUG	Latanoprost SR insert	Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-08-11
• Last updated: 2014-12-08

Locations

1 site across 1 country: United States