RECRUITINGINTERVENTIONAL
Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Nanodropper
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
DEVICE
Regular dropper
Delivers full eye drop volume
Locations (1)
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, United States