Local Anesthetic
Conditions
Keywords
chloroprocaine, eye gel, ocular surface anesthesia
Brief 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. 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
Interventions
DRUGChloroprocaine 3% eye gel
ocular surface anesthesia
DRUGOxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
ocular surface anesthesia
Sponsors
Sintetica SA
Cross Research S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | from day 1 until study end (day 8 or day 15) | Evaluation of safety by assessing the occurrence of adverse events throughout the study |
| Assessing the Product Global Tolerance Graded | day 1, post dose | 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. |
Countries
Italy
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 73 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 36 |
| other Total, other adverse events | 1 / 37 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
None listed