Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority 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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Device: Nanodropper; Device: Regular dropper

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose E Capo-Aponte, OD, PhD; Phone Number: 210-292-2554; Email: Jose.E.CapoAponte.ctr@health.mil
• Study Contact Backup: Name: Jennifer Steger, PhD; Phone Number: 507-405-5676; Email: jenny@nanodropper.com

Study Locations

• United States
  • Texas
    • Lackland Air Force Base, Texas, United States, 78236
      • Recruiting
      • Wilford Hall Ambulatory Surgical Center
      • Contact: Jose E Capo-Aponte, OD, PhD; Phone Number: 210-292-2554; Email: Jose.E.CapoAponte.ctr@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanodroper; Patients are given a Nanodropper to use with their IOP-lowering eyedrops.; Patient returns for a safety check 1 month following the start of Nanodropper use.; At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops without Nanodropper for 3 months.; The patient returns at 6 months for final clinical assessment	Device: Nanodropper; Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
Active Comparator: Regular Dropper; Patient continues using current IOP-lowering eyedrops without Nanodropper adaptor.; At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops with Nanodropper for 3 months.; Patient returns for a safety check 1 month following the start of Nanodropper use.; The patient returns at 6 months for final clinical assessment	Device: Regular dropper; Delivers full eye drop volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: 59th Medical Wing
• Collaborators: Nanodropper, Inc.
• Investigators: Principal Investigator: Alexandra Papp, MD, 59th Medical Wing

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Anticipated): March 17, 2024
• Study Completion (Anticipated): March 17, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Primary Open Angle Glaucoma; Microdrops; Nanodropper
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: C.2022.041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Result of the study will be published in a scientific journal upon completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No