Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population

A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population

The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.

74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia.

The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge

Study Overview

• Status: Not yet recruiting
• Conditions: Local Anesthetic
• Intervention / Treatment: Drug: Chloroprocaine 3% eye gel; Drug: Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Roberta Bianchi; Phone Number: +41795972343; Email: rbianchi@sintetica.com
• Study Contact Backup: Name: Anna Guaita; Phone Number: +41797685488; Email: aguaita@sintetica.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be enrolled in this study, patients must fulfil all these inclusion criteria:

1. Age ≥ one day of life (newborn, infant, child) and 17 years included (not anticipated to turn 18 during the study).

2. Female subjects currently either of:

   • Non-childbearing potential (i.e., premenarchal or physiologically incapable of becoming pregnant, including any female who is surgically sterilized via documented hysterectomy or bilateral tubal ligation), or
   • Childbearing potential (i.e., postmenarchal girls): the subject is eligible to enter and participate in this study if she is not lactating, has a negative pregnancy test and agrees to abstain from intercourses or uses a valid contraceptive method until study completion.
3. Signed written informed consent by both parents or legal representative(s) (unless only one has legal authority). Written informed assent for adolescents aged 12-17 years included and, whenever possible, informed assent for children aged 6 to 11 years included. Ability of the subjects and their parents/legal representative(s) to understand and comply with the protocol requirements, study-specified visit schedule and procedures.
4. Scheduled to undergo a routine clinical procedure which needs local ocular surface anesthesia, including but not limited to applanation tonometry, gonioscopy, Ultrasound Biomicroscopy (UBM), ocular ultrasonography, retinal peripheral examination with blepharostat and scleral indentation.

Exclusion Criteria:

• Patients fulfilling at the inclusion visit one or more of the following exclusion criteria will not be enrolled in the study:

Ophthalmic exclusion criteria

1. Previous ocular surgery less than 6 months before screening
2. Eye movement disorder (nystagmus)
3. History of herpetic keratitis
4. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration, corneal damage and superficial punctuate keratitis)

5. History of ocular traumatism, infection or inflammation within the last 3 months Systemic/non ophthalmic exclusion criteria

   • General history:

6. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasia, hematological diseases, severe psychiatric illness, cardiac rhythm disorders and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study

   • Allergic history:

7. Known hypersensitivity to one of the components of the investigational products Exclusion criteria related to general conditions
8. Non-compliant patient and/or parent(s)/legal representative(s) (e.g., not willing to attend the follow-up visits, way of life interfering with compliance)
9. Participation in another clinical study in the last three months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
10. Already included once in this study Exclusion criteria related to previous and concomitant medications / non-product therapies
11. Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study:

NOT ALLOWED CONCOMITANT MEDICATIONS (washout times) Any change in concomitant anti-depressant medication: no changes permitted during the entire trial duration Any topical ocular treatment: within 15 days before inclusion Systemic opioids and morphine drugs, Sulohonamides, Anticholinesterase drugs: from 15 day before the inclusion visit onwards Any change in other systemic medication already ongoing before the inclusion visit: 7 days before the inclusion visit onwards Other systemic antalgics drugs (except for paracetamol)* from Day 1 onwards

*Paracetamol after primary endpoint assessment and oral, implantable, transdermal, or injectable contraceptives for child-bearing potential girls during the entire study will be allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chloroprocaine 3% gel; The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.	Drug: Chloroprocaine 3% eye gel; ocular surface anesthesia; Other Names: Chemical Abstracts Service (CAS) nr 3858-89-7
Active Comparator: Oxybuprocaine 0,4% solution; The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.	Drug: Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops; ocular surface anesthesia; Other Names: Benoxinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conjunctiva anesthesia with Chloroprocaine 3% eye gel as compared with Oxybuprocaine chlorhydrate 0.4% eye drops	Efficacy outcome: to assess the proportion of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing objective ocular signs	Evaluation of safety by assessing objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, folliculo-papillary conjunctivitis, corneal staining punctations, anterior chamber cells, flare) and other objective ocular signs, assessed by slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO), will be graded according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe.	from day 1 until study end (day 8 or day 15)
Occurrence of adverse events	Evaluation of safety by assessing the occurrence of adverse events throughout the study	from day 1 until study end (day 8 or day 15)
Assessing the product global tolerance graded	Evaluation of safety by assessing the product global tolerance graded by the Investigator by answering the following question "How do you consider the study product global tolerance" using the following scale: 0=very unsatisfactory, 1=unsatisfactory, 2= satisfactory, 3=very satisfactory.	day 1, post dose

Collaborators and Investigators

• Sponsor: Sintetica SA
• Collaborators: Cross Research S.A.
• Investigators: Principal Investigator: Emilio Pedrotti, Prof., Clinica Oculistica dell'Azienda Ospedaliera Integrata di Verona, Policlinico di Borgo Roma (Verona), Italy

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: chloroprocaine; eye gel; ocular surface anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ophthalmic Solutions; Chloroprocaine; Benoxinate
• Other Study ID Numbers: CHL.3-01-2021-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No