The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Novartis Investigative Site
Chevy Chase, Maryland, United States
Novartis Investigative Site
Sioux Falls, South Dakota, United States
Novartis Investigative Site
Draper, Utah, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Visual Analog Scale (VAS) Pre-dose Pain Assessment
VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 6 hours
Average Ocular Pain VAS Assessments
VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 12 hours
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)
Time frame: 6,12, 24, 48 and 72 hours post-operatievly
VAS Pain Assessments
VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 72 hours
Plasma Concentration of SAF312
C Max
Time frame: day1, day 4
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