An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920 (NCT04759339) | Clinical Trial Compass
CompletedPhase 1
An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
United States14 participantsStarted 2021-02-24
Plain-language 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 single topical ocular administration of AG-920 in the randomized study eye.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
ā. Voluntarily provide written informed consent prior to any study-related procedures being performed.
ā. Female subjects of childbearing potential must have negative pregnancy test.
ā. Certified as healthy by clinical assessment.
ā. Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.
ā. Have an Intraocular Pressure between 7 and 30 mmHg inclusive.
ā. Are able to tolerate instillation of Over-The-Counter artificial tear product .
ā. Blood pressure \< 140/90 mmHg and heart rate \< 100 bpm at screening.
Exclusion criteria
ā. Have previously received AG-920.
ā. Have a contraindication to local anesthetics.
ā. Have had ocular surgery or general surgery within the past 90 days.
ā. Have had an intravitreal injection in either eye within 14 days of treatment.
ā. Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.
ā. Have evidence of any current ocular inflammation.
What they're measuring
1
Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920