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

A Randomized, Single-Masked, Active-Controlled, Parallel-Group Evaluation of Safety and the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution (AG-920) in a Pediatric Population

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: AG-920; Drug: Proparacaine Ophthalmic

Detailed Description

A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who 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.

Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • McAllen, Texas, United States, 78503
      • American Genomics Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Pre-pubescent with no childbearing potential
2. Capable of undergoing an eye exam
3. 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.
4. 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.
5. Have a healthy, normal cornea.

Exclusion Criteria:

1. Have participated in an investigational study (drug or device) within the past 30 days.
2. Have a known contraindication to local anesthetics.
3. Children with known autism spectrum disorders or known to have heightened sensitivity.
4. Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
5. Have low visual acuity
6. Manifest nystagmus
7. Have had ocular surgery or general surgery within the past 45 days.
8. Have had an intravitreal injection in either eye within 14 days of randomization.
9. Have ocular surface disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AG-920; 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; AG-920 Sterile Topical Ophthalmic Solution; Other Names: articaine
Active Comparator: Proparacaine; 0.5% Proparacaine Hydrochloride	Drug: Proparacaine Ophthalmic; 0.5% Proparacaine Hydrochloride; Other Names: Proparacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC. Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).	From randomization through study completion (up to 4 days following treatment)

Collaborators and Investigators

• Sponsor: American Genomics, LLC
• Investigators: Study Director: Martin Uram, MD, Medical Expert

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: AG-920; Intravitreal Injection; Articaine; Septocaine; Proparacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Proxymetacaine; Propoxycaine
• Other Study ID Numbers: AG-920-CS304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No