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

Ocular Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05844384
Study type Interventional
Source 59th Medical Wing
Contact Jose E Capo-Aponte, OD, PhD
Phone 210-292-2554
Email Jose.E.CapoAponte.ctr@health.mil
Status Recruiting
Phase N/A
Start date March 17, 2022
Completion date March 17, 2024
View Details
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