Gel or drops? study finds best numbing for Kids' eye tests

NCT ID NCT05926258

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two numbing medicines for children's eye exams: a gel (chloroprocaine) and eye drops (oxybuprocaine). 74 children aged 0-17 received one of the two before their eye exam. Researchers checked how well each numbed the eye and if there were any side effects.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

74 people

The number who actually took part.

Started

May 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (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: * 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 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 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 Exclusion criteria related to previous and concomitant 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162, Italy

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132, Italy

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

    Verona, VR, 37126, Italy

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