Nanodropper microdrop delivery for primary open-angle glaucoma and ocular hypertension
Official title: Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Run by 59th Medical Wing · NCT05844384 · Data updated 2026-11-12
This test will see if Nanodropper microdrops of glaucoma medicines lower eye pressure as well as standard eye drops for adults with primary open-angle glaucoma or ocular hypertension.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | 59th Medical Wing Federal |
| Locations | 1 site (Lackland Air Force Base, Texas) |
| Status | Recruiting |
| Started | March 17, 2022 |
| Main results expected | March 17, 2024 |
| Study ends | March 17, 2024 |
| Registry record updated | May 6, 2023 |
| Trial ID | NCT05844384 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with primary open-angle glaucoma or ocular hypertension who are on no more than two IOP-lowering medications and have had stable disease for at least one year.
✕Probably not a fit
Patients with other types of glaucoma, recent disease progression, use of more than two IOP medications, or recent IOP-lowering surgery (except SLT performed >6 months prior) are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-masked, crossover non-inferiority trial comparing intraocular pressure (IOP) response to standard eyedrops versus Nanodropper-mediated microdrops in adults with primary open-angle glaucoma or ocular hypertension. Each participant will use one delivery method for three months, then cross over to the other method, with mean IOP (mm Hg) ± SEM as the primary efficacy endpoint. Secondary endpoints include safety and usability measured by patient surveys at enrollment and follow-up visits. The study enrolls patients on up to two IOP-lowering medications with stable disease and is conducted at Wilford Hall Ambulatory Surgical Center.
Why it matters
Potential benefit: If successful, Nanodropper could let patients control eye pressure with smaller microdrops that provide similar effectiveness while reducing side effects and medication waste.
How similar studies have gone: Early pilot studies of microdrop delivery have suggested comparable IOP control and reduced ocular exposure, but large randomized non-inferiority trials are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, United States Recruiting
Study contacts
- Principal investigator: Alexandra Papp, MD — 59th Medical Wing
- Study coordinator: Jose E Capo-Aponte, OD, PhD
- Email: Jose.E.CapoAponte.ctr@health.mil
- Phone: 210-292-2554
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.