Local AnestheticPhase 3NCT05926258
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
A Phase 3 study testing Chloroprocaine 3% eye gel and Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops in people with Local Anesthetic, run by Sintetica SA at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Local Anesthetic
- What is being tested?
- Chloroprocaine 3% eye gel and Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesItaly
- Study dates
- 23 May 2024to 13 Mar 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be enrolled in this study, patients must fulfil all these inclusion criteria:
- 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.
Who cannot join
- Patients fulfilling at the inclusion visit one or more of the following exclusion criteria will not be enrolled in the study:
- Ophthalmic exclusion criteria
- 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)
Show all 17Show fewer
- History of ocular traumatism, infection or inflammation within the last 3 months Systemic/non ophthalmic exclusion criteria
- 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:
- Known hypersensitivity to one of the components of the investigational products Exclusion criteria related to general conditions
- 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
- Already included once in this study Exclusion criteria related to previous and concomitant medications / non-product therapies
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS Ospedale San Raffaele
Milan, MI, 20132
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
Ospedale della Donna e del Bambino, Ospedale Borgo Trento, Azienda Ospedaliera Universitaria Integrata
Verona, VR, 37126
About this study
Official title: 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
- Conditions
- Local Anesthetic
- Being tested
- Chloroprocaine 3% eye gel, Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
- Keywords
- chloroprocaine, eye gel, ocular surface anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine 3% eye gelDrug
Also called Chemical Abstracts Service (CAS) nr 3858-89-7
ocular surface anesthesia
Oxybuprocaine Hydrochloride 4 Mg/mL Eye DropsDrug
Also called Benoxinate
ocular surface anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (2)
Number of Participants With Adverse Events
Evaluation of safety by assessing the occurrence of adverse events throughout the study
Measured: 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.
Measured: day 1, post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start23 May 2024
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Local AnestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926258
- Sponsor's protocol ID
- CHL.3-01-2021-M
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2023
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05926258
- Acronym / sponsor ID
- CHL.3-01-2021-M
- Conditions
- Local Anesthetic
- Keywords
- chloroprocaine, eye gel, ocular surface anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 23 May 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine 3% gel | Experimental | Drug: Chloroprocaine 3% eye gelThe 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. |
| Oxybuprocaine 0,4% solution | Active comparator | Drug: Oxybuprocaine Hydrochloride 4 Mg/mL Eye DropsThe 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- Patients fulfilling at the inclusion visit one or more of the following exclusion criteria will not be enrolled in the study:
- Ophthalmic exclusion criteria
- Previous ocular surgery less than 6 months before screening
- Eye movement disorder (nystagmus)
- History of herpetic keratitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroprocaine 3% eye gelAlso: Chemical Abstracts Service (CAS) nr 3858-89-7ocular surface anesthesia | Drug | Chloroprocaine 3% gel |
| Oxybuprocaine Hydrochloride 4 Mg/mL Eye DropsAlso: Benoxinateocular surface anesthesia | Drug | Oxybuprocaine 0,4% solution |
Primary outcome
Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops
Time frame: day 1
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.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: from day 1 until study end (day 8 or day 15)
Assessing the Product Global Tolerance Graded
Time frame: day 1, post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chloroprocaine 3% eye gel and Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops in people with Local Anesthetic, run by Sintetica SA at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.