NCT05844384

Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: 59th Medical Wing · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 will be mean IOP (mm Hg) ± SEM. A secondary objective of this trial is to evaluate Nanodropper's safety and usability. Surveys that have been designed to gain an understanding of the differences in side effects and usability between using Nanodropper-mediated microdrops compared to standard eyedrops will be administered to patients at the enrollment visit and at each follow-up visit.

Conditions

• Ocular Hypertension
• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Nanodropper	Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
DEVICE	Regular dropper	Delivers full eye drop volume

Timeline

• Start date: 2022-03-17
• Primary completion: 2024-03-17
• Completion: 2024-03-17
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study