A Randomized, Observer-Blind Trial Comparing Chloroprocaine Hydrochloride Gel and Oxybuprocaine Eye Drops for Pediatric Ocular Anesthesia

The primary objective of this study 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 is clinically relevant as it aims to determine the most effective local anesthetic for children, potentially improving patient comfort and procedural outcomes.

The secondary objective is to assess the **safety** of Chloroprocaine 3% ophthalmic gel in comparison to Oxybuprocaine chlorhydrate 0.4% eye drops. This evaluation is crucial for ensuring the well-being of pediatric patients during clinical practice, as it will provide insights into the safety profile of these anesthetic agents.

The clinical trial involves a **pediatric population** comprising both male and female outpatients aged from newborn to 17 years, who are scheduled to undergo ocular exams requiring ocular surface anesthesia. The study aims to evaluate the efficacy of Chloroprocaine 3% ophthalmic gel compared to Oxybuprocaine chlorhydrate 0.4% eye drops. The trial population includes individuals who are not anticipated to turn 18 during the study period. 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 trial includes both genders and considers vulnerable populations. However, the sponsor has not provided information regarding the total number of participants. Key lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed as a **prospective**, observer-blind, randomized study to evaluate the efficacy of **Chloroprocaine Hydrochloride** 3% ophthalmic gel compared to **Oxybuprocaine** 0.4% eye drops in providing local anesthesia for ocular procedures in a pediatric population. The trial will involve male and female outpatients aged 0-17 years who require ocular surface anesthesia for routine clinical procedures. The study is expected to commence recruitment on March 15, 2024, and conclude by October 31, 2024.

Participants will be randomly assigned to receive either the test product, Chloroprocaine Hydrochloride eye gel, or the comparator, Oxybuprocaine eye drops. The primary endpoint is the proportion of patients achieving successful conjunctival anesthesia in the right eye five minutes post-administration, assessed using an eye spear sponge. Secondary endpoints include the evaluation of safety through objective ocular signs and adverse events, graded by slit lamp examination or binocular indirect ophthalmoscopy.

The trial will consist of several study visits, beginning with a screening visit to confirm eligibility based on inclusion criteria such as age, informed consent, and the need for ocular anesthesia. Follow-up visits will monitor the efficacy and safety of the treatment, with assessments conducted at specified intervals. The end-of-study visit will finalize data collection and evaluate the overall outcomes of the trial.

Participant involvement is expected to last for the duration of the treatment period, which is limited to a maximum of one day. Conditions that may lead to early termination from the study include the occurrence of severe adverse events or non-compliance with the study protocol. The trial is not classified as a low-intervention study and is categorized as a phase III study, indicating its advanced stage in the clinical research process.

The clinical trial involves the evaluation of **Chloroprocaine Hydrochloride** 30 mg/g eye gel, which is an experimental medication formulated as an eye gel. The active substance, **chloroprocaine hydrochloride**, is a chemical compound used as a local anesthetic. The pharmaceutical form is specifically designed for **ophthalmic use**, and the administration involves instilling the gel into the eye. The dosage is set at a maximum of 2 drops per day, with a total treatment period not exceeding one day. The product is manufactured by SINTETICA S.A. and 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, which serves as the standard-of-care therapy. Like the experimental medication, **oxybuprocaine** is a chemical local anesthetic used for **ophthalmic use**. The administration involves instilling the eye drops, with a maximum dosage of 2 drops per day, and the treatment period is limited to one day. The ATC classification for this substance is S01HA02. The trial aims to compare the clinical efficacy of the experimental **Chloroprocaine Hydrochloride** gel against the standard **Oxybuprocaine** eye drops in a pediatric population. 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 anesthesia in pediatric patients. The primary endpoint for assessing efficacy is the proportion of patients achieving successful conjunctiva 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).