A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population

NCT05325853 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AG-920-CS304
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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 Hydrochloride Ophthalmic Solution.

Conditions

Anesthesia, Local

Keywords

AG-920; Articaine; Septocaine; Intravitreal Injection; Proparacaine

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants in Which an Eye Exam Was Able to be Performed

  Was the investigator was able to perform the eye examination without additional anesthesia

  Two to four minutes following treatment (last drop) of IMP

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From randomization through study completion (up to 4 days following treatment)

Study Arms (2)

AG-920

EXPERIMENTAL

Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.

Drug: AG-920

Proparacaine

ACTIVE COMPARATOR

0.5% Proparacaine Hydrochloride

Drug: Proparacaine Ophthalmic

Interventions

AG-920 DRUG

AG-920 Sterile Topical Ophthalmic Solution

Also known as: articaine

AG-920

Proparacaine Ophthalmic DRUG

0.5% Proparacaine Hydrochloride

Also known as: Proparacaine

Proparacaine

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Genomics, LLC: lead

Study Sites (1)

American Genomics Site 2

McAllen, Texas, 78503, United States

Location

Related Publications (1)

• Gonzalez VH, Uram M, Schupp A, Widmann M, Novack GD. AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients. J Ocul Pharmacol Ther. 2024 Jun;40(5):293-296. doi: 10.1089/jop.2023.0187. Epub 2024 Apr 22.

  PMID: 38647654 DERIVED

MeSH Terms

Interventions

Carticaine; proxymetacaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Martin Uram
• Organization: American Genomics, LLC

aschupp@cmcturnkey.com

973-885-3447

Study Officials

• Martin Uram, MD

  Medical Expert

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or proparacaine into one (study) eye (2 drops 30 seconds apart).

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 6, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Locations

US (1)