Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Texas
Wilford Hall Ambulatory Surgical Center
RECRUITING
Lackland Air Force Base
Contact Information
Primary
Jose E Capo-Aponte, OD, PhD
Jose.E.CapoAponte.ctr@health.mil
210-292-2554
Backup
Jennifer Steger, PhD
jenny@nanodropper.com
507-405-5676
Time Frame
Start Date: 2022-03-17
Estimated Completion Date: 2024-03-17
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: 59th Medical Wing
Collaborators: Nanodropper, Inc.