Recruiting

Nanodropper

Sponsor:

59th Medical Wing

Code:

NCT05844384

Conditions

Ocular Hypertension

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nanodropper

Regular dropper

Study Details

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

Study ID

NCT05844384

Start date

Mar 17, 2022

Status verified date

Apr, 2023

Completion date

Mar 17, 2024

Anticipated

Primary completion date

Mar 17, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Nanodropper

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

Regular dropper

Delivers full eye drop volume

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jose E Capo-Aponte, OD, PhD

210-292-2554Jose.E.CapoAponte.ctr@health.mil

Jennifer Steger, PhD

507-405-5676jenny@nanodropper.com

Locations

Wilford Hall Ambulatory Surgical Center

Recruiting

Lackland Air Force Base, Texas, United States, 78236

Contacts

Jose E Capo-Aponte, OD, PhD

210-292-2554Jose.E.CapoAponte.ctr@health.mil

More Information

Sponsor

59th Medical Wing

Last update posted

May 6, 2023

Last verified

Apr, 2023

Keywords

  • Nanodropper
  • Primary Open Angle Glaucoma
  • Microdrops
  • Ocular Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 59th Medical Wing on 2023-05-06.