Study on the Effectiveness of Chloroprocaine Gel and Oxybuprocaine Drops for Eye Anesthesia in Children Needing Eye Exams

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What is this study about?

This clinical trial is focused on studying the effectiveness of two different local anesthetics used for eye procedures in children. The diseases being studied involve conditions where children, from newborns to 17-year-olds, need anesthesia for eye exams. The treatments being compared are Chloroprocaine Hydrochloride 3% eye gel and Oxybuprocaine 0.4% eye drops. Both medications are used to numb the surface of the eye to make procedures more comfortable for young patients.

The purpose of the study is to evaluate how well these two anesthetics work in providing pain relief during eye exams. The study will involve applying either the eye gel or the eye drops to the surface of the eye and observing the level of anesthesia achieved. The study will also monitor any side effects or reactions to the treatments, ensuring the safety and comfort of the participants. The trial is designed to be observer-blind, meaning the person assessing the results does not know which treatment the participant received, to ensure unbiased results.

Participants will be randomly assigned to receive either the Chloroprocaine Hydrochloride gel or the Oxybuprocaine drops. The study will take place over a short period, with the primary focus on the effectiveness of the anesthesia five minutes after application, just before the eye examination. Safety will be closely monitored throughout the study, with any adverse effects being recorded and evaluated. The study aims to provide valuable information on which anesthetic is more effective and better tolerated in children undergoing eye procedures.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being between the ages of one day and 17 years, and scheduled for an eye procedure requiring local anesthesia.

Consent must be provided by both parents or legal representatives, and assent from the patient if they are aged 12 to 17 years.

2 initial assessment

An initial assessment is conducted to ensure the patient is eligible and to establish a baseline for the study.

This includes a review of the patient’s medical history and a physical examination focused on the eyes.

3 administration of study medication

The patient receives either Chloroprocaine 3% eye gel or Oxybuprocaine 0.4% eye drops as part of the study.

The medication is applied to the eye to provide local anesthesia before the scheduled ocular examination.

4 ocular examination

Five minutes after the administration of the study medication, an ocular examination is performed.

The effectiveness of the anesthesia is assessed using an eye spear sponge to ensure the conjunctiva is numb.

5 safety assessment

Throughout the study, safety assessments are conducted to monitor for any adverse effects.

This includes checking for signs such as eyelid swelling, redness, or discharge, using a slit lamp or binocular indirect ophthalmoscopy.

6 evaluation of product tolerance

The overall tolerance of the study medication is evaluated by the investigator.

The investigator rates the tolerance on a scale from very unsatisfactory to very satisfactory.

7 completion of study

The study is estimated to conclude by October 31, 2024.

Upon completion, the data collected will be analyzed to determine the efficacy and safety of the medications used.

Who Can Join the Study?

Patients must be between the ages of 0 and 17 years old and should not turn 18 during the study.
Female participants must either be unable to become pregnant (for example, they haven’t started menstruating or have had surgery to prevent pregnancy) or, if they can become pregnant, they must not be breastfeeding, have a negative pregnancy test, and agree to avoid pregnancy during the study.
Both parents or legal guardians must sign a consent form. Adolescents aged 12-17 must also sign a form agreeing to participate, and children aged 6-11 should do so if possible. Participants and their guardians must understand and follow the study’s requirements and schedule.
Participants must be scheduled for a routine eye procedure that requires local anesthesia on the eye’s surface. This includes procedures like measuring eye pressure, examining the eye’s drainage angle, using ultrasound to look at the eye, or examining the retina with special tools.

Who Cannot Join the Study?

Children who have any known allergies to the study medications cannot participate.
Children with any eye infections or diseases that could affect the study results are not eligible.
Children who have had any eye surgery recently are excluded from the study.
Children who are currently using other eye medications that might interfere with the study are not allowed to join.
Children with any serious health conditions that could make participation unsafe are not eligible.
Children who are unable to follow the study instructions or procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	15.03.2024

Trial locations

Investigated drugs:

Chloroprocaine is used in this trial as an ophthalmic gel. It is being tested to see how well it works as an anesthetic for eye procedures in children. The gel is applied directly to the eye to numb the area and help prevent pain during medical procedures.

Oxybuprocaine is used in this trial as eye drops. It is also an anesthetic, and the trial aims to compare its effectiveness to that of Chloroprocaine gel. The eye drops are used to numb the eye, making it easier to perform procedures without causing discomfort to the child.

Conjunctival Anesthesia – Conjunctival anesthesia is a temporary loss of sensation in the conjunctiva, the clear tissue covering the white part of the eye and the inside of the eyelids. It is typically induced for medical procedures to prevent discomfort during eye examinations or surgeries. The anesthesia works by blocking nerve signals in the eye, leading to numbness. This condition is usually achieved through the application of anesthetic eye drops or gels. The effects are temporary and wear off after a short period, allowing normal sensation to return. It is commonly used in both adults and children undergoing ocular procedures.

Trial ID:

2023-504477-21-01

Protocol code:

CHL.3-01-2021-M

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Chloroprocaine Gel and Oxybuprocaine Drops for Eye Anesthesia in Children Needing Eye Exams

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?