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Device
Nanodropper for Glaucoma
N/A
Recruiting
Led By Alexandra Papp, MD
Research Sponsored by 59th Medical Wing
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year
On a maximum of 2 IOP lowering medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 6
Awards & highlights
Study Summary
This trial tests an eye drop device to see if it's as safe and effective as standard drops for glaucoma/ocular hypertension patients.
Who is the study for?
This trial is for adults over 18 with primary open-angle glaucoma or ocular hypertension who are on up to two medications to lower eye pressure and have had stable disease for the past year. It's not for those whose condition worsened in the last year, on more than two meds, or who've had certain eye surgeries.Check my eligibility
What is being tested?
The study tests if a Nanodropper, which gives smaller drops of medication, is as safe and effective as regular eyedroppers in delivering treatment for high eye pressure. Participants will try both methods at different times to compare results.See study design
What are the potential side effects?
Since patients use their usual medication but with a different dropper (Nanodropper), side effects should be similar to their current experience. However, there may be new discomforts related to using a new device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition has not worsened in the past year.
Select...
I am using up to 2 medications to lower my eye pressure.
Select...
I am over 18 and have glaucoma or high eye pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in mean intraocular pressure at 6 month
Secondary outcome measures
Change from baseline in mean high contrast visual acuity at 6-month
Change from baseline in mean retinal nerve fiber layer thickness at 6-month
Change from baseline in visual field mean deviation at 6-month
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NanodroperExperimental Treatment1 Intervention
Patients are given a Nanodropper to use with their IOP-lowering eyedrops.
Patient returns for a safety check 1 month following the start of Nanodropper use.
At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops without Nanodropper for 3 months.
The patient returns at 6 months for final clinical assessment
Group II: Regular DropperActive Control1 Intervention
Patient continues using current IOP-lowering eyedrops without Nanodropper adaptor.
At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops with Nanodropper for 3 months.
Patient returns for a safety check 1 month following the start of Nanodropper use.
The patient returns at 6 months for final clinical assessment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nanodropper
2021
N/A
~50
Find a Location
Who is running the clinical trial?
59th Medical WingLead Sponsor
39 Previous Clinical Trials
12,470 Total Patients Enrolled
Nanodropper, Inc.Industry Sponsor
3 Previous Clinical Trials
510 Total Patients Enrolled
2 Trials studying Ocular Hypertension
460 Patients Enrolled for Ocular Hypertension
Alexandra Papp, MDPrincipal Investigator59th Medical Wing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition has not worsened in the past year.I am using up to 2 medications to lower my eye pressure.My eye condition is not primary open-angle glaucoma or related to high eye pressure.My eye condition has worsened in the last year.I am using more than 2 medications to lower my eye pressure.I have not had any eye pressure-lowering surgery or laser treatments, except for SLT over 6 months ago.I am over 18 and have glaucoma or high eye pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Nanodroper
- Group 2: Regular Dropper
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program currently enrolling participants?
"This medical study is actively searching for participants, as indicated on clinicaltrials.gov. It was first advertised on March 17th 2022 and has seen a recent update on May 3rd 2023."
Answered by AI
How many people are participating in this experiment?
"Affirmative, the data on clinicaltrials.gov shows that this medical test is presently recruiting subjects. It was first published on March 17th 2022 and subsequently modified on May 3rd 2023. So far, 30 volunteers have been signed up from a single centre."
Answered by AI
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