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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
ocular surface anesthesia
ocular surface anesthesia
IRCCS Ospedale San Raffaele
Milan, MI, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
Ospedale della Donna e del Bambino, Ospedale Borgo Trento, Azienda Ospedaliera Universitaria Integrata
Verona, VR, Italy
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.
Time frame: day 1
Number of Participants With Adverse Events
Evaluation of safety by assessing the occurrence of adverse events throughout the study
Time frame: 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.
Time frame: day 1, post dose
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