Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension
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.
Interventions
DEVICENanodropper
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
DEVICERegular dropper
Delivers full eye drop volume
Sponsors
Nanodropper, Inc.
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
The investigators performing the vision assessment and measuring the intraocular pressure are masked.
Intervention model description
Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean intraocular pressure at 6 month | Change from baseline to month 6 | Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean high contrast visual acuity at 6-month | Change from baseline to month 6 | Change in the mean uncorrected visual acuity (unit = logMAR) from baseline to month 6 measure with ETDRS chart from baseline at 6 months post-op. |
| Change from baseline in mean retinal nerve fiber layer thickness at 6-month | Change from baseline to month 6 | Change in the mean retinal nerve fiber layer thickness (unit = micrometer) from baseline to month 6 measure with optical coherence tomographer. |
| Change from baseline in visual field mean deviation at 6-month | Change from baseline to month 6 | Change in the visual field mean deviation (unit = decibels) from baseline to month 6measure with Humphreys Visual Field Analyzer. |
Countries
United States
Contacts
Primary ContactJose E Capo-Aponte, OD, PhD
Backup ContactJennifer Steger, PhD
Outcome results
None listed