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Study Comparing 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 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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

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

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
04.09.2023

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 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.

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 ID:
2023-504477-21-00
Protocol code:
CHL.3-01-2021-M
Trial Phase:
Therapeutic confirmatory (Phase III)

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