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Study Comparing Chloroprocaine Gel and Oxybuprocaine Drops for Eye Anesthesia in Children Needing Eye Exams

Verified siteRegistered drugNo placebo
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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 study involves children from newborns up to 17 years old who need anesthesia for eye exams. The two treatments being compared are Chloroprocaine Hydrochloride 3% eye gel and Oxybuprocaine 0.4% eye drops. These medications help numb the surface of the eye to make procedures more comfortable for the patient.

The purpose of the study is to evaluate how well these two anesthetics work in providing the necessary numbing effect for eye exams. During the study, participants will receive either the eye gel or the eye drops before their scheduled eye procedure. The study will observe how effective each treatment is in numbing the eye and will also monitor for any side effects or reactions. The study is designed to ensure that the procedures are safe and comfortable for the children involved.

Participants will be monitored for any signs of discomfort or adverse reactions, such as swelling or redness, after receiving the treatment. The study aims to determine which anesthetic provides better relief and is safer for use in children undergoing eye exams. This information will help doctors choose the best anesthetic for young patients in the future.

The research process

The trial runs in 6 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 12-17 years. For children aged 6-11 years, assent is obtained whenever possible.

  2. Step 2

    Randomization and treatment assignment

    The patient is randomly assigned to receive either Chloroprocaine 3% eye gel or Oxybuprocaine 0.4% eye drops for anesthesia.

    The purpose is to compare the effectiveness of these two treatments in providing anesthesia for eye procedures.

  3. Step 3

    Administration of anesthesia

    The assigned anesthesia product is administered to the patient's right eye.

    The effectiveness of the anesthesia is assessed 5 minutes after administration, just before the eye examination.

  4. Step 4

    Eye examination

    The patient undergoes the scheduled eye examination, which may include procedures like applanation tonometry, gonioscopy, or ocular ultrasonography.

    The examination is conducted to ensure the anesthesia is effective and the procedure can be completed comfortably.

  5. Step 5

    Safety assessment

    Throughout the study, safety is monitored by assessing any objective signs in the eye, such as swelling or redness, using a slit lamp or other examination methods.

    Any adverse events are recorded, and the overall tolerance of the anesthesia product is evaluated by the investigator.

  6. Step 6

    Completion of study participation

    The study participation concludes after the eye examination and safety assessments are completed.

    The study aims to finish by April 30, 2024, with recruitment having started on September 4, 2023.

Who can join the trial?

4 criteria

  • Patients must be between 0 and 17 years old and should not turn 18 during the study.
  • Female participants must either be unable to become pregnant 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 written consent form. Adolescents aged 12-17 need to give their written agreement, and children aged 6-11 should also agree if possible.
  • Participants must be scheduled for a routine eye procedure that requires local anesthesia on the eye 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

  • Patients with a known allergy to any of the study medications cannot participate. An allergy is when your body reacts badly to something, like a rash or trouble breathing.
  • Patients who have had eye surgery in the past 3 months are not eligible. Eye surgery is any operation done on the eye.
  • Patients with an eye infection or inflammation at the time of the study cannot join. An infection is when germs cause illness, and inflammation is when a part of the body becomes red, swollen, and painful.
  • Patients using other eye medications that might interfere with the study drugs are excluded. Interfere means to get in the way or affect how something works.
  • Patients with a serious illness that might affect the study results cannot participate. A serious illness is a health problem that is severe and needs medical attention.
  • Patients who are unable to follow the study instructions are not eligible. This means they cannot do what is needed for the study.
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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 prevent pain during the procedure.

  • Oxybuprocaine

    is used in this trial as eye drops. It is another type of anesthetic that is commonly used to numb the eye for various procedures. The trial aims to compare its effectiveness to that of Chloroprocaine gel in providing anesthesia for children undergoing eye treatments.

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 use in pediatric patients undergoing eye examinations. The main therapeutic indication is to provide surface anesthesia for ocular procedures. Chloroprocaine works by blocking nerve signals in the eye, preventing pain during examinations. 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 efficacy in providing anesthesia during eye exams in children. The primary therapeutic use is to numb the eye surface for medical procedures. Oxybuprocaine functions by inhibiting nerve signal transmission, thereby reducing pain sensation. It belongs to the pharmacological class of local anesthetics.

Investigated diseases

Conjunctival Anesthesia – This condition involves the 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. The effect is usually temporary and wears off after a short period. During the anesthesia, patients may not feel any pain or discomfort in the treated area. It is commonly used in both adults and children undergoing ocular procedures.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504477-21-00Protocol codeCHL.3-01-2021-MEstimated enrolment74 patientsSponsorSintetica S.A.

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