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

NCT05844384 | Recruiting FDA Device

• 1 other identifier: C.2022.041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Hypertension; Primary Open Angle Glaucoma

Keywords

Nanodropper; Primary Open Angle Glaucoma; Microdrops; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in mean high contrast visual acuity at 6-month

  Change from baseline to month 6

• Change from baseline in mean retinal nerve fiber layer thickness at 6-month

  Change from baseline to month 6

• Change from baseline in visual field mean deviation at 6-month

  Change from baseline to month 6

Study Arms (2)

Nanodroper

EXPERIMENTAL

* 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

Regular Dropper

ACTIVE COMPARATOR

* 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

Interventions

Nanodropper DEVICE

Nanodropper delivers 1/5 of eye drop volume compared to regular droppers

Nanodroper

Regular dropper DEVICE

Delivers full eye drop volume

Regular Dropper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 59th Medical Wing: lead
• Nanodropper, Inc.: collaborator

Study Sites (1)

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78236, United States

RECRUITING

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Officials

• Alexandra Papp, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators performing the vision assessment and measuring the intraocular pressure are masked.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: May 6, 2023
• Study Start: March 17, 2022
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)