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

Healthy Clinical Trial

Official title:

An Open Label, Non-Comparative Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of Articaine Sterile Topical Ophthalmic Solution (AG-920)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759339
• Other study ID #: AG-920-CS101
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: April 2022
• Source: American Genomics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 administration of AG-920 in the randomized study eye.

In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye. The study eye will be randomized. The single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye. Subjects will have pharmacokinetic (PK) blood samples taken at multiple periods over 24 hours following dosing. Safety will be assessed by monitoring any changes in heart rate, blood pressure, intraocular pressure, visual acuity, biomicroscopy, and AEs.

The study will consist of 3 clinical visits: Screening Visit, Dosing and PK Blood Level Sampling (0-8 hours) Visit and a Follow Up Visit (with PK blood level sampling 24 hours after study drug treatment).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Key Inclusion Criteria:

1. Voluntarily provide written informed consent prior to any study-related procedures being performed.

2. Female subjects of childbearing potential must have negative pregnancy test.

3. Certified as healthy by clinical assessment.

4. Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.

5. Have an Intraocular Pressure between 7 and 30 mmHg inclusive.

6. Are able to tolerate instillation of Over-The-Counter artificial tear product .

7. Blood pressure < 140/90 mmHg and heart rate < 100 bpm at screening.

Key Exclusion Criteria:

1. Have previously received AG-920.

2. Have a contraindication to local anesthetics.

3. Have had ocular surgery or general surgery within the past 90 days.

4. Have had an intravitreal injection in either eye within 14 days of treatment.

5. Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.

6. Have evidence of any current ocular inflammation.

7. Have a known current condition which could cause vision problems.

8. Current ocular allergy symptoms.

9. Have donated or lost more than 400 mL of blood within 12 weeks.

10. Plasma donation within 7 days prior to the first dosing.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
American Genomics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Treatment Emergent Adverse Events (TEAE)	TEAEs will be summarized by system organ class (SOC) and preferred term.	randomization through follow up (2 days)