Corneal DiseasesPhase 4NCT06636708
Efficacy of Nanodropper-mediated Topical Anesthetic
A Phase 4 study testing Nanodropper and Proparacaine HCl 0.5% and Standard Eye Drop Bottle with Proparacaine HCl 0.5% in people with Corneal Diseases and Effectiveness of Microdrops, run by Columbia University at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Diseases, Effectiveness of Microdrops
- What is being tested?
- Nanodropper and Proparacaine HCl 0.5% and Standard Eye Drop Bottle with Proparacaine HCl 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 24 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent for topical anesthesia delivery
- Ability to verbally respond to pain
- At least 18 years of age
Who cannot join
- Have a contraindication to local anesthetics
- History of intravitreal injections
- History of ocular surgery
- History of vitreous or retinal surgery
- Preexisting diagnosis of ocular surface disease requiring punctal plug placement
- Evidence of any current ocular inflammation
Show all 9Show fewer
- Any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface
- Use of contact lenses in the past 2 weeks
- Use of exclusionary medications: Topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl
The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. The Nanodropper is designed to administer smaller-sized drops, or microdrops.
Participants will:
Read more
- Complete a baseline eye exam.
- Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye.
- Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops).
- Tell the researchers if they feel pain during the eye sensation tests.
- Complete a survey about their experience with the eyedrops and testing procedure.
This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.
- Conditions
- Corneal Diseases, Effectiveness of Microdrops
- Being tested
- Nanodropper and Proparacaine HCl 0.5%, Standard Eye Drop Bottle with Proparacaine HCl 0.5%
- Keywords
- Corneal anesthesia, Nanodropper
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanodropper and Proparacaine HCl 0.5%Combination product
The Nanodropper is an eyedrop bottle adaptor that creates smaller eyedrops by coupling to an existing eyedrop bottle. This intervention involves the administration of proparacaine HCl 0.5% using the Nanodropper.
Standard Eye Drop Bottle with Proparacaine HCl 0.5%Combination product
This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle.
| Study group | Role | What they receive |
|---|---|---|
| Standard Eye Drops | Active comparator | Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl Receives: Combination Product: Standard Eye Drop Bottle with Proparacaine HCl 0.5% |
| Nanodropper | Experimental | Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl Receives: Combination Product: Nanodropper and Proparacaine HCl 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Anesthesia
The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 Dec 2024
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aakriti G. Shukla, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636708
- Sponsor's protocol ID
- AAAU9824
- Status last verified
- Feb 2026
- First submitted
- 8 Oct 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
St Peter DM, Steger JS, Patnaik JL, Davis N, Kahook MY, Seibold LK. Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the Nanodropper Bottle Adaptor. Med Devices (Auckl). 2023 Apr 6;16:71-79. doi: 10.2147/MDER.S397654. eCollection 2023.
PubMed 37056302Palmer DJ, Robin AL, McCabe CM, Chang DF; Ophthalmic Instrument Cleaning and Sterilization Task Force. Reducing topical drug waste in ophthalmic surgery: multisociety position paper. J Cataract Refract Surg. 2022 Sep 1;48(9):1073-1077. doi: 10.1097/j.jcrs.0000000000000975.
PubMed 35608314Moore DB, Walton C, Moeller KL, Slabaugh MA, Mudumbai RC, Chen PP. Prevalence of self-reported early glaucoma eye drop bottle exhaustion and associated risk factors: a patient survey. BMC Ophthalmol. 2014 Jun 13;14:79. doi: 10.1186/1471-2415-14-79.
PubMed 24927769
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl
- ClinicalTrials.gov ID
- NCT06636708
- Acronym / sponsor ID
- AAAU9824
- Conditions
- Corneal Diseases, Effectiveness of Microdrops
- Keywords
- Corneal anesthesia, Nanodropper
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. The Nanodropper is designed to administer smaller-sized drops, or microdrops.
Participants will:
- Complete a baseline eye exam.
- Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye.
- Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops).
- Tell the researchers if they feel pain during the eye sensation tests.
- Complete a survey about their experience with the eyedrops and testing procedure.
This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Eye Drops | Active comparator | Combination Product: Standard Eye Drop Bottle with Proparacaine HCl 0.5%Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl |
| Nanodropper | Experimental | Combination Product: Nanodropper and Proparacaine HCl 0.5%Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide informed consent for topical anesthesia delivery
- Ability to verbally respond to pain
- At least 18 years of age
Key exclusion criteria (9 listed)
- Have a contraindication to local anesthetics
- History of intravitreal injections
- History of ocular surgery
- History of vitreous or retinal surgery
- Preexisting diagnosis of ocular surface disease requiring punctal plug placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanodropper and Proparacaine HCl 0.5%The Nanodropper is an eyedrop bottle adaptor that creates smaller eyedrops by coupling to an existing eyedrop bottle. This intervention involves the administration of proparacaine HCl 0.5% using the Nanodropper. | Combination product | Nanodropper |
| Standard Eye Drop Bottle with Proparacaine HCl 0.5%This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle. | Combination product | Standard Eye Drops |
Primary outcome
Corneal Anesthesia
Time frame: 5 minutes
The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 37056302St Peter DM, Steger JS, Patnaik JL, Davis N, Kahook MY, Seibold LK. Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the Nanodropper Bottle Adaptor. Med Devices (Auckl). 2023 Apr 6;16:71-79. doi: 10.2147/MDER.S397654. eCollection 2023.
- Background: PubMed 35608314Palmer DJ, Robin AL, McCabe CM, Chang DF; Ophthalmic Instrument Cleaning and Sterilization Task Force. Reducing topical drug waste in ophthalmic surgery: multisociety position paper. J Cataract Refract Surg. 2022 Sep 1;48(9):1073-1077. doi: 10.1097/j.jcrs.0000000000000975.
- Background: PubMed 24927769Moore DB, Walton C, Moeller KL, Slabaugh MA, Mudumbai RC, Chen PP. Prevalence of self-reported early glaucoma eye drop bottle exhaustion and associated risk factors: a patient survey. BMC Ophthalmol. 2014 Jun 13;14:79. doi: 10.1186/1471-2415-14-79.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nanodropper and Proparacaine HCl 0.5% and Standard Eye Drop Bottle with Proparacaine HCl 0.5% in people with Corneal Diseases and Effectiveness of Microdrops, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Anesthesia (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06636708, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.