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

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 (notanticipated to turn 18 during the study).

2. Female subjects currently either of:

• Non-childbearing potential (i.e., premenarchal or physiologically incapable ofbecoming pregnant, including any female who is surgically sterilized viadocumented hysterectomy or bilateral tubal ligation), or

• Childbearing potential (i.e., postmenarchal girls): the subject is eligible toenter and participate in this study if she is not lactating, has a negativepregnancy test and agrees to abstain from intercourses or uses a validcontraceptive method until study completion.

3. Signed written informed consent by both parents or legal representative(s) (unlessonly one has legal authority). Written informed assent for adolescents aged 12-17years included and, whenever possible, informed assent for children aged 6 to 11years included. Ability of the subjects and their parents/legal representative(s) tounderstand and comply with the protocol requirements, study-specified visit scheduleand procedures.

4. Scheduled to undergo a routine clinical procedure which needs local ocular surfaceanesthesia, including but not limited to applanation tonometry, gonioscopy,Ultrasound Biomicroscopy (UBM), ocular ultrasonography, retinal peripheralexamination with blepharostat and scleral indentation.

Exclusion Criteria:

• Patients fulfilling at the inclusion visit one or more of the following exclusioncriteria 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 monthsSystemic/non ophthalmic exclusion criteria

• General history:

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

• Allergic history:

7. Known hypersensitivity to one of the components of the investigational productsExclusion criteria related to general conditions

8. Non-compliant patient and/or parent(s)/legal representative(s) (e.g., not willing toattend 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 themonth that follows the last visit of the previous study and the first day of thepresent study

10. Already included once in this study Exclusion criteria related to previous andconcomitant 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