RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-17
Study Completion:2024-03-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05844384

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * POAG/OHTN patients above the age of 18 years.
  2. * On a maximum of 2 IOP lowering medications.
  3. * Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year.
  1. * Glaucoma not of the POAG or OHTN variety or other retinal diseases.
  2. * Progression of disease within the preceding 1 year (IOP elevation, optic disc cupping, visual field changes).
  3. * Using more than 2 IOP-lowering medications.
  4. * IOP-lowering surgical interventions or lasers except for SLT. SLT may have been completed 6+ months prior to study start date.

Contacts and Locations

Study Contact

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

Principal Investigator

Alexandra Papp, MD
PRINCIPAL_INVESTIGATOR
59th Medical Wing

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 59th Medical Wing

  • Alexandra Papp, MD, PRINCIPAL_INVESTIGATOR, 59th Medical Wing

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-17
Study Completion Date2024-03-17

Study Record Updates

Study Start Date2022-03-17
Study Completion Date2024-03-17

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Ocular Hypertension
  • Primary Open Angle Glaucoma