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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Ocular Hypertension
Intervention / Treatment

-

Contacts and Locations

Lackland Air Force Base

Wilford Hall Ambulatory Surgical Center, Lackland Air Force Base, Texas, United States, 78236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

59th Medical Wing,

Alexandra Papp, MD, PRINCIPAL_INVESTIGATOR, 59th Medical Wing

Study Record Dates

2024-03-17