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

NCT ID: NCT05926258

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-03-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chloroprocaine 3% eye gel

Intervention Type: DRUG

ocular surface anesthesia

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.

Group Type: ACTIVE_COMPARATOR

Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops

Intervention Type: DRUG

ocular surface anesthesia

Interventions

Chloroprocaine 3% eye gel

ocular surface anesthesia

Intervention Type: DRUG

Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops

ocular surface anesthesia

Intervention Type: DRUG

Other Intervention Names

Chemical Abstracts Service (CAS) nr 3858-89-7; Benoxinate

Eligibility Criteria

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

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)

• 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:

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

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Research S.A.

INDUSTRY

Sponsor Role: collaborator

Sintetica SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Ospedale San Raffaele

Milan, MI, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

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

Verona, VR, Italy

Countries

Italy

Other Identifiers

CHL.3-01-2021-M

Identifier Type: -

Identifier Source: org_study_id