Status:
COMPLETED
An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
Lead Sponsor:
American Genomics, LLC
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, non-comparative study in healthy subjects performed in the US. It is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a ...
Detailed Description
This is a Phase 1, open-label, non-comparative study in healthy subjects designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular admin...
Eligibility Criteria
Inclusion
- Key
- Voluntarily provide written informed consent prior to any study-related procedures being performed.
- Female subjects of childbearing potential must have negative pregnancy test.
- Certified as healthy by clinical assessment.
- Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.
- Have an Intraocular Pressure between 7 and 30 mmHg inclusive.
- Are able to tolerate instillation of Over-The-Counter artificial tear product .
- Blood pressure \< 140/90 mmHg and heart rate \< 100 bpm at screening.
- Key
Exclusion
- Have previously received AG-920.
- Have a contraindication to local anesthetics.
- Have had ocular surgery or general surgery within the past 90 days.
- Have had an intravitreal injection in either eye within 14 days of treatment.
- Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.
- Have evidence of any current ocular inflammation.
- Have a known current condition which could cause vision problems.
- Current ocular allergy symptoms.
- Have donated or lost more than 400 mL of blood within 12 weeks.
- Plasma donation within 7 days prior to the first dosing.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04759339
Start Date
February 24 2021
End Date
February 25 2021
Last Update
April 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Celerion
Lincoln, Nebraska, United States, 68502