Clinical trial NCT05844384: Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Official title: Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ocular Hypertension
Primary Open Angle Glaucoma
Keywords: Nanodropper
Primary Open Angle Glaucoma
Microdrops
Ocular Hypertension
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: Nanodropper, Inc.
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The primary objective of this study is to compare changes in intraocular pressure (IOP) in a population of POAG and OHTN patients in response to administration of 1) standard drops of IOP lowering medications and 2) Nanodropper-mediated microdrops of IOP-lowering medications. The hypothesis is that Nanodropper-mediated microdrops of IOP-lowering medications will not result in a significant difference in IOP relative to standard drops of IOP-lowering medications after three months of daily eyedrop administration with each delivery system. The primary outcome measure for this efficacy endpoint will be mean IOP (mm Hg) ± SEM. A secondary objective of this trial is to evaluate Nanodropper's safety and usability. Surveys that have been designed to gain an understanding of the differences in side effects and usability between using Nanodropper-mediated microdrops compared to standard eyedrops will be administered to patients at the enrollment visit and at each follow-up visit.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in mean intraocular pressure at 6 month
timeFrame: Change from baseline to month 6
Secondary outcomes:
measure: Change from baseline in mean high contrast visual acuity at 6-month
timeFrame: Change from baseline to month 6
measure: Change from baseline in mean retinal nerve fiber layer thickness at 6-month
timeFrame: Change from baseline to month 6
measure: Change from baseline in visual field mean deviation at 6-month
timeFrame: Change from baseline to month 6
Other outcomes:
Locations:
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: 59th Medical Wing
name: Alexandra Papp, MD
role: PRINCIPAL_INVESTIGATOR
References: