Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension

NCT05277870 | Unknown FDA Device

• 1 other identifier: STUDY00013248
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

glaucoma; ocular hypertension

Outcome Measures

Primary Outcomes (1)

• IOP (mm Hg)

  Mean IOP ± SEM following three months of treatment with each modality. The change in IOP from baseline and the percent change in IOP from baseline are supportive efficacy endpoints.

  6 months

Secondary Outcomes (3)

• Adverse events

  6 months

• Premature bottle exhaustion

  6 months

• Socioeconomic strain

  6 months

Study Arms (2)

control

ACTIVE COMPARATOR

Standard eyedrops of IOP-lowering medications

Device: control

Nanodropper

EXPERIMENTAL

Microdrops of IOP-lowering medications using Nanodropper adaptor

Device: Nanodropper adaptor

Interventions

Nanodropper adaptor DEVICE

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

Nanodropper

control DEVICE

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Related Links

• Nanodropper website

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Raghu Mudumbai

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Vuletic

CONTACT

206-520-9728; simona@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Ophthalmology

Model Details: crossover assignment

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: February 28, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)