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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

6 criteria

  • 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.
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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.

What is already known about the treatment

  • Chloroprocaine

    Chloroprocaine is administered as a 3% ophthalmic gel, applied directly to the eye's surface to provide local anesthesia. It is currently being studied in clinical trials to assess its effectiveness compared to other anesthetics for ocular procedures in children. The main therapeutic use is to numb the eye during examinations or minor surgeries. Chloroprocaine works by blocking nerve signals in the eye, preventing pain sensations. It is classified as a local anesthetic.

  • Oxybuprocaine

    Oxybuprocaine is administered as 0.4% eye drops, applied directly to the eye to achieve local anesthesia. It is being evaluated in clinical trials for its effectiveness in providing anesthesia during ocular exams in children. The primary use is to numb the eye for procedures or examinations. Oxybuprocaine functions by inhibiting nerve signal transmission in the eye, thus preventing pain. It belongs to the pharmacological class of local anesthetics.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504477-21-01Protocol codeCHL.3-01-2021-MEstimated enrolment74 patientsSponsorSintetica S.A.

sourced from the EU Clinical Trials Register and site verification

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