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Completed

NCT Number: NCT05325853

A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution 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.

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Key information

Conditions

Anesthesia, Local

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

American Genomics Site 2

McAllen, Texas, 78503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AG-920

Drug

AG-920 Sterile Topical Ophthalmic Solution

Other names: articaine

Proparacaine Ophthalmic

Drug

0.5% Proparacaine Hydrochloride

Other names: Proparacaine

Primary outcomes

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

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

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

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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

    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).

Sponsors and collaborators

Lead sponsor

American Genomics, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2022
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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