Gel or drops? study finds best numbing for Kids' eye tests
NCT ID NCT05926258
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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74 people
The number who actually took part.
- Started
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May 2024
- Finished
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Mar 2025
- Lead sponsor
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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
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1 day to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162, Italy
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IRCCS Ospedale San Raffaele
Milan, MI, 20132, Italy
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Ospedale della Donna e del Bambino, Ospedale Borgo Trento, Azienda Ospedaliera Universitaria Integrata
Verona, VR, 37126, Italy
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