Nanodropper Use in Glaucoma Patients

This study is testing if using a Nanodropper, which delivers a smaller eye drop, works as well as a regular dropper for people with primary open-angle glaucoma (POAG) or ocular hypertension (OHTN). The Nanodropper delivers 1/5 the volume of a regular eye drop. We want to see if the Nanodropper can lower your eye pressure (intraocular pressure or IOP) just as effectively as standard drops over 6 months. You might be able to join if you are over 18, have POAG or OHTN, and are on no more than two eye pressure-lowering medications with stable disease. The study is currently unclear on its recruitment status.

Study design
This is a randomized, single-masked, crossover study involving 30 participants.
What's involved
You will use both the Nanodropper and a regular dropper for your eye drops, and complete surveys about side effects and usability at enrollment and follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Your eye pressure will be measured at 6 months after starting the study.

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NCT05844384

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

Recruiting
NAAges 18+Interventional
59th Medical Wing
~30 participants
Updated 2023-05-06 on ClinicalTrials.gov
What's tested:NanodropperRegular dropper

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in mean intraocular pressure at 6 month
Measured over Change from baseline to month 6
Ocular Hypertension
Primary Open Angle Glaucoma
1 sites across 1 states
Texas1
  • Alexandra Papp, MD · PRINCIPAL_INVESTIGATOR · 59th Medical Wing

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Change from baseline in mean intraocular pressure at 6 monthChange from baseline to month 6

    Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer