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Recruiting NCT05844384

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

No phase Interventional Ocular Hypertension Primary Open Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nanodropper, Regular dropper.
Who it may be relevant to
Registry conditions: Ocular Hypertension, Primary Open Angle Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Nanodropper
    Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
  • Device Regular dropper
    Delivers full eye drop volume

Primary outcome measures

  • Change from baseline in mean intraocular pressure at 6 month [Time frame: Change from baseline to month 6]
Secondary outcome measures (3)
  • Change from baseline in mean high contrast visual acuity at 6-month [Time frame: Change from baseline to month 6]
  • Change from baseline in mean retinal nerve fiber layer thickness at 6-month [Time frame: Change from baseline to month 6]
  • Change from baseline in visual field mean deviation at 6-month [Time frame: Change from baseline to month 6]

Eligibility criteria

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 prior to study start date.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Wilford Hall Ambulatory Surgical Center — Lackland Air Force Base

Publications

  • Steger JS, Capo-Aponte JE, Papp A, Schulte AJ, Grewal EP, Song AJ, Colantuoni E, Kelstrom JC, Robin AL. Real-world efficacy, safety, and usability of a microvolume eyedrop delivery device in glaucoma: prospective randomized crossover trial. J Cataract Refract Surg. 2026 Apr 1;52(4):385-392. doi: 10.1097/j.jcrs.0000000000001823. PMID 41185150

Identifiers

NCT: NCT05844384 · C.2022.041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗