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

NCT05926258 | Completed Phase 3 Results

• 1 other identifier: CHL.3-01-2021-M
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Local Anesthetic

Keywords

chloroprocaine; eye gel; ocular surface anesthesia

Outcome Measures

Primary Outcomes (1)

• Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops

  Efficacy outcome: assess 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 Outcomes (2)

• Number of Participants With Adverse Events

  from day 1 until study end (day 8 or day 15)

• Assessing the Product Global Tolerance Graded

  day 1, post dose

Study Arms (2)

Chloroprocaine 3% gel

EXPERIMENTAL

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

Oxybuprocaine 0,4% solution

ACTIVE COMPARATOR

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

Interventions

Chloroprocaine 3% eye gel DRUG

ocular surface anesthesia

Also known as: Chemical Abstracts Service (CAS) nr 3858-89-7

Chloroprocaine 3% gel

Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops DRUG

ocular surface anesthesia

Also known as: Benoxinate

Oxybuprocaine 0,4% solution

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Previous ocular surgery less than 6 months before screening
• Eye movement disorder (nystagmus)
• History of herpetic keratitis
• Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration, corneal damage and superficial punctuate keratitis)
• General history:
• 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:
• 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)
• 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
• Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study:
• \*Paracetamol after primary endpoint assessment and oral, implantable, transdermal, or injectable contraceptives for child-bearing potential girls during the entire study will be allowed

Sponsors & Collaborators

• Sintetica SA: lead
• Cross Research S.A.: collaborator

Study Sites (3)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

Location

Ospedale della Donna e del Bambino, Ospedale Borgo Trento, Azienda Ospedaliera Universitaria Integrata

Verona, VR, 37126, Italy

Location

MeSH Terms

Interventions

chloroprocaine; benoxinate; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Anna Guaita, PhD
• Organization: Sinetica SA

aguaita@sintetica.com

0916404250

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 3, 2023
• Study Start: May 23, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)