An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920

NCT04759339 | Completed Phase 1 FDA Drug

• 1 other identifier: AG-920-CS101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 single topical ocular administration of AG-920 in the randomized study eye.

Conditions

Healthy

Keywords

articaine; AG-920

Outcome Measures

Primary Outcomes (1)

• Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920

  Plasma levels of articaine and its primary metabolite (articainic acid)

  8 hours

Secondary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAE)

  randomization through follow up (2 days)

Study Arms (1)

AG-920

EXPERIMENTAL

Subjects will receive a single dose of articaine sterile topical ophthalmic solution in one eye only. The study eye will be randomized. The single dose will be administered by the clinic staff as two drops in study eye 30 seconds apart.

Drug: AG-920

Interventions

AG-920 DRUG

AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%

Also known as: Articaine Sterile Topical Ophthalmic Solution

AG-920

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Genomics, LLC: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• Verhoeven R, Uram M, Schupp A, Rasmussen S, Widmann M, Novack GD. Early Nonclinical and Clinical Development of AG-920, a Repurposed Topical Ocular Anesthetic. J Ocul Pharmacol Ther. 2022 Sep;38(7):481-488. doi: 10.1089/jop.2022.0026. Epub 2022 Jul 18.

  PMID: 35852839 DERIVED

Study Officials

• Martin Uram, MD

  American Genomics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, non-comparative study of the systemic exposure to articaine after topical ocular dosing of articaine sterile topical ophthalmic solution

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 24, 2021
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)