A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Po… (NCT05325853) | Clinical Trial Compass
CompletedPhase 3
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
United States61 participantsStarted 2022-04-06
Plain-language summary
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.
Who can participate
Age range10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Pre-pubescent with no childbearing potential
✓. Capable of undergoing an eye exam
✓. Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
✓. Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
✓. Have a healthy, normal cornea.
Exclusion criteria
✕. Have participated in an investigational study (drug or device) within the past 30 days.
✕. Have a known contraindication to local anesthetics.
✕. Children with known autism spectrum disorders or known to have heightened sensitivity.
✕. Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
✕. Have low visual acuity
✕. Manifest nystagmus
✕. Have had ocular surgery or general surgery within the past 45 days.
✕
What they're measuring
1
The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Timeframe: Two to four minutes following treatment (last drop) of IMP