Status:
COMPLETED
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Lead Sponsor:
American Genomics, LLC
Conditions:
Anesthesia, Local
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05325853
Start Date
April 6 2022
End Date
May 27 2022
Last Update
October 25 2023
Active Locations (1)
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1
American Genomics Site 2
McAllen, Texas, United States, 78503