male/female outpatients, aged 0-17 years scheduled to undergo ocular exams with a need of ocular surface anesthesia.
Conditions
Brief summary
Primary endpoint will be to assess the proportion 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.
Detailed description
Safety endpoints: - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells, flare) and other objective ocular signs, assessed by slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO), will be graded according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe., Safety endpoint: Adverse events occurrence throughout the study, Safety endpoints: Product global tolerance will be 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.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be to assess the proportion 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 |
|---|---|
| Safety endpoints: - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells, flare) and other objective ocular signs, assessed by slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO), will be graded according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe., Safety endpoint: Adverse events occurrence throughout the study, Safety endpoints: Product global tolerance will be 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