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

NCT05844384 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Nanodropper

Nanodropper delivers 1/5 of eye drop volume compared to regular droppers

DEVICE

Regular dropper

Delivers full eye drop volume

Sponsors & Collaborators

  • Nanodropper, Inc.

    collaborator INDUSTRY

  • 59th Medical Wing

    lead FED

Principal Investigators

  • Alexandra Papp, MD · 59th Medical Wing

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2024-03-17
Completion
2024-03-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844384 on ClinicalTrials.gov