RecruitingNot ApplicableNCT05844384

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


Sponsor

59th Medical Wing

Enrollment

30 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

Interventions

DEVICENanodropper

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

DEVICERegular dropper

Delivers full eye drop volume


Locations(1)

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, United States

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NCT05844384


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