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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sintetica S.A.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

14 May 2024 → 13 Mar 2025

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sintetica S.A

External identifiers

EU CT number

2023-504477-21-01

WHO UTN

U1111-1293-4201

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy

The primary objective of the study is to evaluate the efficacy of Chloroprocaine 3% ophthalmic gel as compared to Oxybuprocaine chlorhydrate 0.4% eye drops anesthesia for clinical practice in pediatric population

Secondary objectives 1

1. The secondary objective of the study is to evaluate the safety of Chloroprocaine 3% ophthalmic gel as compared to Oxybuprocaine chlorhydrate 0.4% eye drops anesthesia for clinical practice in pediatric population.

Conditions and MedDRA coding

male/female outpatients, aged 0-17 years scheduled to undergo ocular exams with a need of ocular surface anesthesia.

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000639-PIP06-20

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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. 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. 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. 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 4

1. 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
2. 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
3. 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
4. Exclusion criteria related to previous and concomitant medications / nonproduct 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: BEFORE INCLUSION (30,15,7 days) and Inclusion (day 1): Any change in concomitant anti-depressant medication, Any topical ocular treatment. BEFORE INCLUSION (15,7 days) and Inclusion (day 1): Systemic opioids and morphine drugs. BEFORE INCLUSION (7 days) and Inclusion (day 1): Any change in other systemic medication already ongoing before inclusion visit. Inclusion (day 1): Others systemic antalgics drugs*. *Paracetamol after primary endpoint assessment and oral, implantable, transdermal, or injectable contraceptives for child-bearing potential girls during the entire study will be allowed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint will be 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.

Secondary endpoints 3

1. Safety endpoints: - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, 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.
2. Safety endpoint: Adverse events occurrence throughout the study
3. Safety endpoints: Product global tolerance will be 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sintetica S.A.

Sponsor organisation

Sintetica S.A.

Address

Via Penate 5

City

Mendrisio

Postcode

6850

Country

Switzerland

Scientific contact point

Organisation

Sintetica S.A.

Contact name

Sergio Cantoreggi

Public contact point

Organisation

Sintetica S.A.

Contact name

Sergio Cantoreggi

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications