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| Name | Class |
|---|---|
| Nanodropper, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanodroper | Experimental |
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| Regular Dropper | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanodropper | Device | Nanodropper delivers 1/5 of eye drop volume compared to regular droppers |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean intraocular pressure at 6 month | Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer | Change from baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean high contrast visual acuity at 6-month | 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 to month 6 |
| Change from baseline in mean retinal nerve fiber layer thickness at 6-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose E Capo-Aponte, OD, PhD | Contact | 210-292-2554 | Jose.E.CapoAponte.ctr@health.mil | |
| Jennifer Steger, PhD | Contact | 507-405-5676 | jenny@nanodropper.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Papp, MD | 59th Medical Wing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Ambulatory Surgical Center | Recruiting | Lackland Air Force Base | Texas | 78236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41185150 | Derived | Steger JS, Capo-Aponte JE, Papp A, Schulte AJ, Grewal EP, Song AJ, Colantuoni E, Kelstrom JC, Robin AL. Real-world efficacy, safety, and usability of a microvolume eyedrop delivery device in glaucoma: prospective randomized crossover trial. J Cataract Refract Surg. 2026 Apr 1;52(4):385-392. doi: 10.1097/j.jcrs.0000000000001823. |
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Result of the study will be published in a scientific journal upon completion.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2022 | Jan 13, 2023 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2025 | Aug 26, 2025 | 1 |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
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The investigators performing the vision assessment and measuring the intraocular pressure are masked.
| Regular dropper | Device | Delivers full eye drop volume |
|
Change in the mean retinal nerve fiber layer thickness (unit = micrometer) from baseline to month 6 measure with optical coherence tomographer. |
| Change from baseline to month 6 |
| Change from baseline in visual field mean deviation at 6-month | Change in the visual field mean deviation (unit = decibels) from baseline to month 6measure with Humphreys Visual Field Analyzer. | Change from baseline to month 6 |