Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Julius Oatts, MD
Headshot of Julius Oatts
Julius Oatts

Description

Summary

Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.

Details

The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial. Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients. Secondary Aim: Assess access to eye drops and frequency of pharmacy refill requests. Stable glaucoma participants and ocular hypertension participants of all ages will be randomized to either use Nanodropper for drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 2, 4, and 6 months. New bottles of medication and any prescription refills required during the study will be purchased and provided to study participants.

Keywords

Glaucoma Eye Glaucoma Ocular Hypertension Pediatric Glaucoma Nannodropper iCare

Eligibility

You can join if…

Open to people ages 2 years and up

Glaucoma Arm: Children:

  • Patients with either stable glaucoma or ocular hypertension.
  • Patients who are 2-17 years old and younger than 18 years old will be enrolled.
  • Participants are on 1-2 IOP- lowering prescriptions, with no clinical indications of disease progression for at least12 months prior to the time of recruitment

Glaucoma Arm: Adult:

  • Patients with stable glaucoma.
  • Patients who are 18+ years old.
  • Participants are on 1-2 IOP- lowering prescriptions, with no clinical indications of disease progression for at least12 months prior to the time of recruitment

You CAN'T join if...

Glaucoma Arm: Children:

  • Patients with uncontrolled glaucoma will not be enrolled.
  • Patients who are newborns, infants, or toddlers (< 2 years old) will not be enrolled.

Glaucoma Arm: Adult:

  • Patients with uncontrolled glaucoma will not be enrolled.

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Julius Oatts, MD
    Dr. Julius Oatts is a pediatric ophthalmologist and a pediatric glaucoma specialist who specializes in the medical and surgical treatment of children with common eye diseases as well as glaucoma, a rare condition in children. His research focuses on the most accurate ways to measure eye pressure in children.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05273385
Study Type
Interventional
Last Updated