Ocular Hypertension Clinical Trial
Official title:
Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients
Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of
latanoprost in treating glaucoma.
Hypothesis: The investigators have already evaluated carrier stability, drug partitioning,
in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes
upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the
investigators hypothesize that this would be safe and efficacious in humans as well.
Methodology: A pilot study to assess a liposome formulation containing latanoprost. The
investigators will recruit 6 study subjects with eyes that have raised IOP, for
subconjunctival injection of this liposome formulation. The recruited eye will be injected
and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the
eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.
Importance: If proven safe, this method of drug delivery could potentially be used for
treatment of raised intraocular pressures in blinding conditions such as glaucoma.
The number of recorded adverse events and intolerance to the subconjunctival injection procedure by the participants during the study period was used as a measure of safety. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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