Nanodropper-Mediated Anesthetic for Eye Conditions

Overseen By Aakriti G Shukla, MD MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Columbia University

Must not be taking: Steroid drops, NSAIDs, IOP drops, antivirals

Disqualifiers: Ocular surgery, Ocular inflammation, Contact lenses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of an eye-numbing drop called proparacaine when administered in two different ways. One eye will receive the drop from a standard bottle, while the other will receive it from a Nanodropper, a device that uses smaller drops. The goal is to determine if smaller drops can numb the eye as effectively while using less medication, potentially saving money and reducing waste. Individuals who haven't had eye surgeries or certain eye conditions and can describe their pain may be suitable for the trial. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications to participate in this trial. Specifically, you cannot use topical steroid drops, non-steroidal anti-inflammatory drops, eye drops that lower eye pressure, anti-viral medications for herpes, or opioids.

What is the safety track record for the Nanodropper-mediated anesthetic?

Earlier studies have shown that proparacaine, the numbing drop used in this trial, is safe for people. It is commonly used for eye treatments and surgeries. Past research has also tested the Nanodropper, which delivers smaller drops. Studies found it was well tolerated, with no major side effects reported.

These findings suggest that both the regular eye drops and the Nanodropper method are generally safe. The Nanodropper might offer a new way to use less medication, potentially reducing costs and waste. Prospective participants may find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Nanodropper-mediated anesthetic for eye conditions because it offers a new way to deliver topical anesthetics more efficiently. Unlike standard eye drops, which can waste a lot of medication, the Nanodropper delivers microdrops, potentially reducing waste and improving precision. This method maintains the same active ingredient, 0.5% proparacaine HCl, but its targeted delivery could enhance patient comfort and reduce side effects, making it a promising advancement in eye care.

What evidence suggests that the Nanodropper-mediated anesthetic is effective for eye conditions?

Research has shown that the Nanodropper delivers eye medications effectively while using less medicine. It achieves this by administering smaller drops, known as microdrops, which still provide the necessary numbing effect. In this trial, eyes assigned to the Nanodropper arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl, while the standard eye drops arm will receive a standard drop of 0.5% proparacaine HCl. One study found that the Nanodropper significantly reduced the amount of medicine used without losing effectiveness. This trial aims to compare the speed and duration of numbing with these smaller drops versus regular ones. If successful, this approach could save money and reduce waste by using less medication. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to provide informed consent for topical anesthesia delivery

I can tell someone when I'm in pain.

Exclusion Criteria

Use of contact lenses in the past year

I have had surgery on the back part of my eye.

I have an eye condition that needed a punctal plug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Eye Exam

Participants complete a baseline eye exam before receiving treatment

1 day

1 visit (in-person)

Treatment

Participants receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye, followed by testing for numbness at specific time points

1 day

1 visit (in-person)

Follow-up

Participants complete a survey about their experience with the eyedrops and testing procedure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nanodropper-mediated Topical Anesthetic

Trial Overview 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.

How Is the Trial Designed?

Group I: Nanodropper Experimental Treatment 1 Intervention

Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl

Group II: Standard Eye Drops Active Control 1 Intervention

Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study involving 12 volunteers, the use of 5% lidocaine cream (ELA-Max) after Er:YAG laser ablation of the stratum corneum significantly reduced pain during subsequent laser resurfacing compared to conventional topical anesthesia.

While laser-assisted topical anesthesia improved pain tolerance for most subjects, it still did not provide sufficient anesthesia for all individuals undergoing full-face resurfacing, indicating a need for additional pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of erbium:yttrium-aluminum-garnet laser-assisted delivery of topical anesthetic. Yun, PL., Tachihara, R., Anderson, RR.[2019]

Unpreserved 0.4% benoxinate hydrochloride does not significantly affect tear film stability, suggesting it is a safe option for procedures requiring anesthetic without compromising tear film integrity.

The study's methods, which included assessing tear thinning time and corneal sensitivity in normal eyes, provide a framework for further research on how preserved anesthetics might impact tear film stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tear thinning time and topical anesthesia as assessed using the HIRCAL grid and the NCCA. Blades, KJ., Murphy, PJ., Patel, S.[2019]

In a study involving 79 geriatric patients, the lidocaine/tetracaine patch significantly reduced procedural pain compared to a placebo, with a notable difference in pain ratings on the visual analog scale (VAS).

The lidocaine/tetracaine patch was found to be safe, with no reported adverse events, making it an effective noninvasive option for local anesthesia in older patients undergoing minor dermatologic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study evaluating the lidocaine/tetracaine patch for induction of local anesthesia prior to minor dermatologic procedures in geriatric patients. Schecter, AK., Pariser, DM., Pariser, RJ., et al.[2019]

In a study of 2,020 cataract surgeries, topical anaesthesia (TA) was associated with significantly fewer intra-operative and early postoperative complications compared to peribulbar anaesthesia (PBA), indicating a safer option for patients.

The study highlighted that elderly patients (65 years and older) experienced a higher rate of intra-operative complications, suggesting that TA may be particularly beneficial for this age group when performing routine cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic adverse events: a comparison between topical and peribulbar anaesthesia in cataract surgery. Stupp, T., Hassouna, I., Soppart, K., et al.[2007]

In a study of 100 cataract surgeries, 62% of patients undergoing manual extracapsular cataract extraction (ECCE) and 74% of those undergoing phacoemulsification reported no pain during the procedure when using lidocaine 2% gel as the sole anesthetic.

The use of lidocaine gel was found to be safe and effective, with a low mean pain score (0.99 for ECCE and 0.72 for phacoemulsification), and it provided additional lubrication that helped facilitate the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anesthesia using lidocaine gel for cataract surgery. Assia, EI., Pras, E., Yehezkel, M., et al.[2019]

A new temperature-responsive hydrogel was developed for delivering local anesthetics effectively to the full thickness of eyelid skin, utilizing FDA-approved materials.

The hydrogel demonstrated a remarkably high capacity for loading local anesthetic drugs, suggesting it could enhance the efficacy of pain management in ocular procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering hydrogel nanoparticles to enhance transdermal local anaesthetic delivery in human eyelid skin. Ozkahraman, B., Emeriewen, K., Saleh, GM., et al.[2022]

Topical anesthetics are widely used in both medical and non-medical settings, but their increased use, particularly by non-physicians, has led to a rise in complications such as ineffective anesthesia and allergic reactions.

The review highlights the importance of understanding the techniques, formulations, and appropriate applications of topical anesthetics in cosmetic and laser dermatology to minimize risks and enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anesthetics for cosmetic and laser dermatology. Amin, SP., Goldberg, DJ.[2015]

In a randomized, double-blind, crossover study comparing two laser output energies for topical anesthesia before venipuncture, both 2.0 J/cm2 and 3.5 J/cm2 were found to be equally effective, with no significant difference in pain scores.

The study indicates that using the lower energy of 2.0 J/cm2 is just as effective as the higher energy of 3.5 J/cm2 for topical anesthesia, while also maintaining a similar profile of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of laser-assisted drug delivery at two output energies for enhancing the delivery of topically applied LMX-4 cream prior to venipuncture. Koh, JL., Harrison, D., Swanson, V., et al.[2013]

In a study of 156 patients undergoing intravitreal injections, both topical tetracaine and lidocaine provided similar levels of anesthesia, with no significant difference in pain scores immediately after the injection.

Topical diclofenac did not significantly reduce pain scores after the injection, indicating that it may not be an effective addition to the post-injection treatment protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular pain after intravitreal injection. Sanabria, MR., Montero, JA., Losada, MV., et al.[2015]

Topical gel anesthesia with 2% lidocaine provides similar pain relief compared to subconjunctival injection anesthesia for intravitreal injections, as shown in a study involving 28 patients across two groups.

Using lidocaine gel resulted in significantly lower rates of chemosis and subconjunctival hemorrhage compared to the traditional subconjunctival injection method, indicating a safer option for patient comfort during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine gel anesthesia for intravitreal drug administration. Kozak, I., Cheng, L., Freeman, WR.[2022]

Topical anesthetics are effective for providing pain relief in various medical fields, and their effectiveness can be improved by using higher concentrations, physical and chemical enhancers, and lipid delivery systems.

When using topical anesthetics, it is crucial to consider factors such as the patient's age, weight, and potential side effects to ensure safe and effective application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anesthesia. Kumar, M., Chawla, R., Goyal, M.[2022]

In a 3-month observational study of local anaesthesia (LA) for intraocular surgery in the UK, the overall incidence of adverse events was 2.7% for local complications and 0.9% for systemic complications, indicating that while LA is generally safe, there are notable risks.

Eighteen life-threatening events were reported, along with cases of patients experiencing seizures or requiring intensive care, highlighting the need for vigilance and preparedness for serious adverse events in all patients undergoing intraocular surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Survey of Local Anaesthesia for Ocular Surgery. II. Safety profiles of local anaesthesia techniques. Eke, T., Thompson, JR.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06636708

Efficacy of Nanodropper-mediated Topical Anesthetic This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical ...

2. trialx.com trialx.com/clinical-trials/listings/316187/efficacy-of-nanodropper-mediated-topical-anesthetic/

Efficacy of Nanodropper-mediated Topical Anesthetic This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and ...

3. trial.medpath.com trial.medpath.com/clinical-trial/22028695a0e57ea8/nct06636708-evaluation-nanodropper-microdrops-vs-standard-drops-proparacaine-hcl

Efficacy of Nanodropper-mediated Topical Anesthetic | MedPath 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, ...

4. nanodropper.com nanodropper.com/wp-content/uploads/2024/09/Nanodropper-Clinical-Data-Summary.pdf

Nanodropper-Clinical-Data-Summary.pdf Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the. Nanodropper Bottle Adaptor. Mean ± SEM , **** p<0.0001. St. Peter DM, Steger JS ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10108985/

Randomized Trial to Evaluate the Efficacy of the Nanodropper ... The purpose of this study was to evaluate the effectiveness of pediatric pupillary dilation and cycloplegia using a novel small-volume eye-drop adapter, the ...

6. withpower.com withpower.com/trial/phase-4-corneal-diseases-10-2024-cd32a

Nanodropper-Mediated Anesthetic for Eye Conditions Is Nanodropper-mediated anesthetic generally safe for use in humans? Topical anesthetics, like those used in eye surgeries, are generally safe but can have ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9570464/

Assessment of Efficacy and Safety Using PPAR-γ Agonist ... The NCs were shown to be well tolerated, and no signs of irritancy or alterations of the eye properties were detected by the in vitro HET-CAM test and in vivo ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06636708/efficacy-of-nanodropper-mediated-topical-anesthetic

Efficacy of Nanodropper-mediated Topical Anesthetic 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 ...

9. glance.eyesoneyecare.com glance.eyesoneyecare.com/stories/2024-03-22/study-finds-nanodropper-adaptor-demonstrates-efficacy-and-safety-as-glaucoma-treatment/

Study finds Nanodropper Adaptor demonstrates efficacy ... In all, Nanodropper reported that there was no clinically significant difference in the IOP-lowering effects of Nanodropper-administered ...