Recruiting

Nanodropper vs. Standard Eyedropper

Sponsor:

University of Washington

Code:

NCT05277870

Conditions

Glaucoma, Open-Angle

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nanodropper adaptor

control

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, efficacy, and usability of an eyedrop bottle adaptor that creates smaller eyedrops, Nanodropper, in an open-angle glaucoma/ocular hypertension patient population.

Conditions

Glaucoma, Open-Angle

Ocular Hypertension

Study ID

NCT05277870

Start date

Feb 28, 2022

Status verified date

Mar, 2022

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥18 years old
  • Primary open-angle glaucoma (OAG) diagnosis
  • Ocular hypertension (OHT) diagnosis
  • Corneal thickness <600 µm
  • Use 1-2 IOP-lowering eyedrop medications that are compatible with Nanodropper
  • OAG/OHT must be well-controlled (defined as ≥2 IOP measurements collected within 6 months of recruitment that are ≤21 mm Hg with variability of ±3 mm Hg)
  • OAG/OHT must be progression-free (as judged by the clinician and based on ≥2 stable OCT and visual field tests collected in the 6 months prior to recruitment)

Exclusion Criteria:

  • Uncontrolled glaucoma (IOP >21 mmHg)
  • Use of >2 medications for treatment of OAG/OHT
  • Use of eyedrop medications that are incompatible with Nanodropper
  • OAG/OHT progression (as judged by the clinician within the past 6 months)
  • Eye surgery including laser procedures (e.g., SLT, iridotomy) within 6 months of recruitment
  • Diagnosis of acute angle-closure glaucoma and/or other retinal diseases

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: control

Standard eyedrops of IOP-lowering medications

experimental: Nanodropper

Microdrops of IOP-lowering medications using Nanodropper adaptor

Interventions

Nanodropper adaptor

Patients will use their standard prescription for open-angle glaucoma or ocular hypertension with a Nanodropper attachment on the medication bottle.

control

Patients will use their prescribed IOP-lowering medication using standard eyedropper on the medication bottle.

Primary outcome measure

  • IOP (mm Hg) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Simona Vuletic

206-520-9728simona@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Simona Vuletic, MD

206-520-9728simona@uw.edu

Brian Gomer

206-520-9728bgome001@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Mar 14, 2022

Last verified

Mar, 2022

Keywords

  • glaucoma
  • ocular hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2022-03-14.