Evaluation of Chloroprocaine Hydrochloride 3% Gel Versus Oxybuprocaine 0.4% Eye Drops for Ocular Surface Anesthesia in Pediatric Patients

The primary objective of this clinical trial is to evaluate the **efficacy** of Chloroprocaine 3% ophthalmic gel compared to Oxybuprocaine chlorhydrate 0.4% eye drops for anesthesia in pediatric patients undergoing ocular examinations. This assessment is clinically relevant as it aims to determine the most effective local anesthetic for children, potentially improving patient comfort and procedural outcomes during ocular procedures.

The secondary objective is to evaluate the safety of Chloroprocaine 3% ophthalmic gel in comparison to Oxybuprocaine chlorhydrate 0.4% eye drops. This is crucial for ensuring that the anesthetic used does not pose additional risks to the pediatric population, thereby supporting safer clinical practices.

The clinical trial involves a study population of **male** and **female** outpatients aged 0 to 17 years who are scheduled to undergo ocular exams requiring ocular surface anesthesia. The sponsor has not provided the total number of participants. The trial population includes individuals from newborns to adolescents, with a focus on evaluating the efficacy of Chloroprocaine 3% ophthalmic gel compared to Oxybuprocaine chlorhydrate 0.4% eye drops in a pediatric setting. Participants are selected based on their need for local ocular surface anesthesia for routine clinical procedures such as applanation tonometry, gonioscopy, and ocular ultrasonography. The study does not specifically target a vulnerable population, and both genders are included. The trial does not specify any particular lifestyle considerations such as diet or physical activity.

The clinical trial is designed as a **prospective, observer-blind, randomized** study to evaluate the efficacy of **Chloroprocaine Hydrochloride 30 mg/g eye gel** compared to **Oxybuprocaine 0.4% eye drops** for ocular surface anesthesia in a pediatric population. The trial will involve male and female outpatients aged 0-17 years who are scheduled to undergo ocular exams requiring local anesthesia. The primary objective is to assess the proportion of patients achieving successful conjunctival anesthesia in the right eye five minutes post-administration of the study product, evaluated using an eye spear sponge. Secondary safety endpoints include the assessment of objective ocular signs such as palpebral edema and conjunctival hyperemia, graded on a scale from 0 (none) to 3 (severe), and the occurrence of adverse events throughout the study.

The trial is expected to commence recruitment on September 4, 2023, and conclude by April 30, 2024. Participants will be involved in the study for a maximum treatment period of one day, with the administration of the study product limited to two drops. The study visits will include an initial screening visit to confirm eligibility based on inclusion criteria such as age and the need for ocular anesthesia, followed by the administration of the study product and subsequent ocular examination. The end-of-study visit will involve a final assessment of ocular signs and the collection of any adverse event data. Conditions that may lead to early termination from the study include the inability to comply with protocol requirements or the occurrence of severe adverse events. The trial is not classified as a low-intervention study and is categorized as a phase III study.

The clinical trial involves the use of **Chloroprocaine Hydrochloride** 30 mg/g eye gel as the experimental medication. This pharmaceutical form is an eye gel, specifically designed for **ophthalmic use**. The active substance, **chloroprocaine hydrochloride**, is a chemical compound provided by SINTETICA S.A. The administration of this medication is limited to a maximum of 2 drops per day, with a total maximum dose of 2 drops over the treatment period. The treatment period is restricted to a single day. The eye gel is classified under the ATC code N01BA04, indicating its role as a local anesthetic. Participant compliance with the dosing schedule will be monitored to ensure adherence to the protocol.

The comparator treatment in this study is **Oxybuprocaine** 0.4% eye drops. This medication is also intended for **ophthalmic use** and serves as a local anesthetic. The dosage regimen for Oxybuprocaine is identical to that of the experimental medication, with a maximum of 2 drops per day and a total maximum dose of 2 drops over the course of one day. The ATC code for Oxybuprocaine is S01HA02. As with the experimental treatment, participant compliance with the administration schedule will be closely monitored to ensure the integrity of the trial results.

The clinical trial aims to evaluate the efficacy of **Chloroprocaine Hydrochloride** 3% ophthalmic gel compared to Oxybuprocaine 0.4% eye drops for local anesthesia in pediatric patients. The primary endpoint for assessing efficacy is the proportion of patients achieving successful conjunctival anesthesia in the right eye, measured 5 minutes post-administration of the study product, immediately before the ocular examination. This assessment will be conducted using an eye spear sponge.

Secondary endpoints focus on safety and include the evaluation of objective ocular signs such as palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, and anterior chamber cells and flare. These will be graded using a scale from 0 (none) to 3 (severe) through slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO). Additionally, the occurrence of adverse events throughout the study will be monitored. The global tolerance of the product will be assessed by the investigator using a scale from 0 (very unsatisfactory) to 3 (very satisfactory).