59th Medical Wing
This randomized, single-masked, crossover, non-inferiority trial aims to evaluate the safety and efficacy of Nanodropper-mediated microdrops of ocular hypotensive topical treatments (experimental intervention) compared to standard drops of the same medication(s) (active comparator) in Wilford Hall Ambulatory Surgical Center (WHASC) primary open-angle glaucoma (POAG) and ocular hypertension (OHTN) patients.
The primary objective of this study is to compare changes in intraocular pressure (IOP) in a population of POAG and OHTN patients in response to administration of 1) standard drops of IOP lowering medications and 2) Nanodropper-mediated microdrops of IOP-lowering medications. The hypothesis is that Nanodropper-mediated microdrops of IOP-lowering medications will not result in a significant difference in IOP relative to standard drops of IOP-lowering medications after three months of daily eyedrop administration with each delivery system. The primary outcome measure for this efficacy endpoint w…
Inclusion Criteria: * POAG/OHTN patients above the age of 18 years. * On a maximum of 2 IOP lowering medications. * Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year. Exclusion Criteria: * Glaucoma not of the POAG or OHTN variety or other retinal diseases. * Progression of disease within the preceding 1 year (IOP elevation, optic disc cupping, visual field changes). * Using more than 2 IOP-lowering medications. * IOP-lowering surgical interventions or lasers except for SLT. SLT may have been completed 6+ months p…
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
Delivers full eye drop volume
Arctuva estimate
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