Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsor59th Medical Wing
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nanodropper
- Regular dropper
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
59th Medical Wing
Lead sponsor
Nanodropper, Inc.
Collaborator
Source ClinicalTrials.gov