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Nanodropper-Mediated Anesthetic for Eye Conditions
Phase 4
Waitlist Available
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Be older than 18 years old
Must not have
History of vitreous or retinal surgery
Preexisting diagnosis of ocular surface disease requiring punctal plug placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to compare the effectiveness of numbing eye drops administered using a standard eye dropper versus a 'Nanodropper' adaptor, which delivers smaller drops. Participants will receive numbing
Who is the study for?
This trial is for individuals with corneal diseases or dry eye syndrome. Participants will undergo a baseline eye exam and must be comfortable receiving numbing drops in each eye. There are no specific inclusion or exclusion criteria provided, so it's important to contact the study team for detailed eligibility information.
What is being tested?
The trial tests the effectiveness of a Nanodropper adaptor versus a standard eye drop bottle when administering Proparacaine HCl 0.5% anesthetic drops. It measures onset and duration of numbness on the surface of the eye at several time intervals after application.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the numbing drops, possible irritation from different dropper methods, and reactions during sensation testing such as pain or prolonged numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 had surgery on the back part of my eye.
Select...
I have an eye condition that needed a punctal plug.
Select...
I have had injections into my eye.
Select...
I currently have eye inflammation.
Select...
I have a lasting eye condition that affects how my eye surface feels.
Select...
I am not using any topical steroids, NSAIDs, eye drops for pressure, anti-herpes medications, or opioids.
Select...
I have had eye surgery in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Corneal Anesthesia
Secondary study objectives
Mean duration of anesthetic effect
Mean time to no pain/anesthesia onset
Patient-Reported Outcomes
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NanodropperExperimental Treatment1 Intervention
Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl
Group II: Standard Eye DropsActive Control1 Intervention
Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,768,940 Total Patients Enrolled