A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Completed · Phase 3
Conditions studied: Anesthesia, Local
In brief
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.
Key facts
- Study ID
- NCT05325853
- Run by
- American Genomics, LLC
- People needed
- 61
- Starts
- 2022-04-06
- Expected to finish
- 2022-05-27
- Last updated by the study team
- 2023-10-25
Who can join
Age: any, up to 10. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Have had an intravitreal injection in either eye within 14 days of randomization.
- Have ocular surface disease.
Where it is running
- American Genomics Site 2 — McAllen, Texas, United States
Full record on ClinicalTrials.gov
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