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Device

Nanodropper Adaptor for Glaucoma

N/A
Recruiting
Led By Raghu Mudumbai
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Use 1-2 IOP-lowering eyedrop medications that are compatible with Nanodropper
Must not have
Diagnosis of acute angle-closure glaucoma and/or other retinal diseases
Use of eyedrop medications that are incompatible with Nanodropper
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether an eyedrop bottle adaptor that creates smaller droplets is safe and effective for people with glaucoma or ocular hypertension.

Who is the study for?
This trial is for adults over 18 with well-controlled open-angle glaucoma or ocular hypertension, meaning their eye pressure has been stable and not too high. They should be using 1-2 compatible eyedrop medications and have a corneal thickness less than 600 µm. People with uncontrolled glaucoma, on more than two medications, or recent eye surgery can't participate.
What is being tested?
The study is testing the Nanodropper adaptor against standard eyedroppers in patients with glaucoma or ocular hypertension. The goal is to see if the Nanodropper, which makes smaller drops, is safe, effective, and user-friendly compared to regular droppers.
What are the potential side effects?
Since this trial involves an adaptor for administering existing medication rather than a new drug itself, side effects may be limited to local discomfort or potential issues related to improper dosing if the device doesn't perform as expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eye pressure has been stable and below 21 mm Hg recently.
Select...
I use 1-2 eye drops that work with Nanodropper for my eye pressure.
Select...
I have been diagnosed with open-angle glaucoma.
Select...
I have been diagnosed with high eye pressure.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with acute angle-closure glaucoma or another retinal disease.
Select...
I use eyedrops that cannot be used with a Nanodropper.
Select...
My eye pressure is not higher than 21 mmHg.
Select...
I use more than two medications for my glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IOP (mm Hg)
Secondary study objectives
Adverse events
Premature bottle exhaustion
Socioeconomic strain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NanodropperExperimental Treatment1 Intervention
Microdrops of IOP-lowering medications using Nanodropper adaptor
Group II: controlActive Control1 Intervention
Standard eyedrops of IOP-lowering medications
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nanodropper adaptor
2021
N/A
~420

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,815 Previous Clinical Trials
1,912,898 Total Patients Enrolled
Raghu MudumbaiPrincipal InvestigatorUniversity of Washington

Media Library

Control (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05277870 — N/A
Ocular Hypertension Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT05277870 — N/A
~26 spots leftby Jun 2025
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