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

Part of paid clinical trials in Lackland Air Force Base, Texas.

Sponsor
59th Medical Wing
Study ID
NCT05844384
Status
Recruiting
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Conditions

  • Ocular Hypertension
  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanodropper — DEVICE
    Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
  • Regular dropper — DEVICE
    Delivers full eye drop volume

Study Details

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.

Key Dates

Start date
Mar 17, 2022
Status verified
Apr 2023
Primary completion
Mar 17, 2024
Completion
Mar 17, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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
  • 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

Primary Outcome Measure

Change from baseline in mean intraocular pressure at 6 month [ Time Frame: Change from baseline to month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wilford Hall Ambulatory Surgical CenterLackland Air Force BaseTexas78236
Jose E Capo-Aponte, OD, PhD
[email protected]
210-292-2554

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Wilford Hall Ambulatory Surgical Center· Lackland Air Force Base, TX

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