Nanodropper-Mediated Anesthetic for Eye Conditions

Overseen By Aakriti G Shukla, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Columbia University

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

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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: 1. Complete a baseline eye exam. 2. Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye. 3. Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops). 4. Tell the researchers if they feel pain during the eye sensation tests. 5. 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.

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 data supports the effectiveness of the Nanodropper-mediated Topical Anesthetic treatment for eye conditions?

Research on laser-assisted drug delivery shows it can help topical anesthetics work faster, which might suggest that similar methods like Nanodropper could improve the effectiveness of anesthetics for eye conditions. ^{1 2 3 4 5}

Is Nanodropper-mediated anesthetic generally safe for use in humans?

Topical anesthetics, like those used in eye surgeries, are generally safe but can have complications such as allergies or ineffective anesthesia. Unpreserved formulations are considered safer for tear film stability than preserved ones. ^{3 6 7 8 9}

How does the Nanodropper-Mediated Anesthetic treatment differ from other treatments for eye conditions?

The Nanodropper-Mediated Anesthetic treatment is unique because it likely uses a specialized delivery system to administer anesthetics directly to the eye, potentially improving precision and reducing waste compared to traditional methods. This approach may enhance the effectiveness of topical anesthetics by ensuring better penetration and coverage, which is not typically achieved with standard eye dropper methods. ^{1 4 10 11 12}

Eligibility Criteria

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

I am 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Nanodropper-mediated Topical Anesthetic (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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of erbium:yttrium-aluminum-garnet laser-assisted delivery of topical anesthetic. [2019]

2. United States 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. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Topical anesthetics for cosmetic and laser dermatology. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Lidocaine gel anesthesia for intravitreal drug administration. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Ocular pain after intravitreal injection. [2015]

6. England pubmed.ncbi.nlm.nih.gov

The National Survey of Local Anaesthesia for Ocular Surgery. II. Safety profiles of local anaesthesia techniques. [2016]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Systemic adverse events: a comparison between topical and peribulbar anaesthesia in cataract surgery. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Tear thinning time and topical anesthesia as assessed using the HIRCAL grid and the NCCA. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Topical anesthesia using lidocaine gel for cataract surgery. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Engineering hydrogel nanoparticles to enhance transdermal local anaesthetic delivery in human eyelid skin. [2022]

11. United States 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. [2019]

12. India pubmed.ncbi.nlm.nih.gov

Topical anesthesia. [2022]