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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My eye pressure has been stable and below 21 mm Hg recently.
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I use 1-2 eye drops that work with Nanodropper for my eye pressure.
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I have been diagnosed with open-angle glaucoma.
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I have been diagnosed with high eye pressure.
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I am 18 years old or older.

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

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

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
1,732 Previous Clinical Trials
1,841,964 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in the present clinical trial?

"Affirmative, there is information on clinicaltrials.gov that confirms the active recruitment of patients for this medical trial. Originally posted at the end of February 2022, it was most recently updated in early March and requires 150 volunteers from a single site to participate."

Answered by AI

Is it still possible to participate in this research endeavor?

"According to clinicaltrials.gov, enrollment for this trial is still ongoing following its initial posting on February 28th 2022 and last update on March 3rd 2022."

Answered by AI
~56 spots leftby Jun 2025