Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Recruiting · NCT05844384 · Interventional (participants receive a specific treatment) · Lead sponsor: 59th Medical Wing
View the official record on ClinicalTrials.gov →Interventions studied
NanodropperRegular dropper
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Wilford Hall Ambulatory Surgical Center - Lackland Air Force Base, Texas, United States