CompletedNCT05325853Updated Oct 25, 2023Results posted

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

A Phase 3 interventional study of AG-920 and Proparacaine Ophthalmic in Anesthesia, Local, sponsored by American Genomics, LLC. Completed at 1 site in United States. Open to participants aged Up to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by American Genomics, LLC · Phase 3, Interventional, and Supportive care

Phase: Phase 3
Study type: Interventional
Enrollment: 61
Allocation: Randomized
Ages: Up to 10 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Anesthesia, Local

Keywords

AG-920
Articaine
Septocaine
Intravitreal Injection
Proparacaine

In context

Lead sponsor

American Genomics, LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 10 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 61 participants (actual)

Study arms

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
Active comparator
Proparacaine
0.5% Proparacaine Hydrochloride
Drug: Proparacaine Ophthalmic

Interventions

DrugAG-920
AG-920 Sterile Topical Ophthalmic Solution
Also known as: articaine
DrugProparacaine Ophthalmic
0.5% Proparacaine Hydrochloride
Also known as: Proparacaine

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Oct 25, 2023

Participant flow

Sixty (60) pediatric subjects were randomized and treated in a phase 1 unit between 6 April 2022 to 27 May 2022.

Participant flow — Overall Study
Milestone	AG-920	Proparacaine
Started	30	30
Completed	30	30
Not completed	0	0

Outcome measures

PrimaryThe 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

Time frame:: Two to four minutes following treatment (last drop) of IMP
Reported as:: Count of participants · Participants

The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Participants	AG-920	Proparacaine
The Proportion of Participants in Which an Eye Exam Was Able to be Performed	30	30

SecondaryNumber 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).

Time frame:: From randomization through study completion (up to 4 days following treatment)
Reported as:: Count of participants · Participants

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Participants	AG-920	Proparacaine
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	0	0

Adverse events

Collected over Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed. If a subject had an ongoing AE at the time of study completion, the event was to be followed-up according to the site's standard of care and the subject provided appropriate medical care until the event resolved or stabilized.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AG-920	0/30 (0%)	0/30 (0%)	0/30 (0%)
Proparacaine	0/30 (0%)	0/30 (0%)	0/30 (0%)

Baseline characteristics

Four analysis populations were defined: Randomized Population, Safety Population, Intent-to-Treat (ITT) Population , Per-Protocol (PP) Population. The safety, ITT and PP populations included 60 subjects. Randomized Population completed Day 1. Safety Population are subjects who received at least one drop of the dose (2 drops). ITT subjects received at least one dose (2 drops) and PP population were all randomized subjects who completed the study treatment with no major protocol violations.

Age, Categorical
Age, Categorical(Participants)	AG-920	Proparacaine	Total
<=18 years	30	30	60
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	AG-920	Proparacaine	Total
Mean	5.2 ± 3.1	6.3 ± 2.5	5.8 ± 2.9

Sex: Female, Male
Sex: Female, Male(Participants)	AG-920	Proparacaine	Total
Female	17	16	33
Male	13	14	27

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	AG-920	Proparacaine	Total
Hispanic or Latino	30	29	59
Not Hispanic or Latino	0	1	1
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AG-920	Proparacaine	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	30	29	59
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	AG-920	Proparacaine	Total
United States	30	30	60

Study Eye
Study Eye(Participants)	AG-920	Proparacaine	Total
Left Eye	15	15	30
Right Eye	15	15	30

Color of Iris
Color of Iris(Participants)	AG-920	Proparacaine	Total
Brown	30	28	58
Green	0	2	2

Study locations

1 site

American Genomics Site 2
McAllen, Texas 78503, United States

References and documents

Study documents

Study protocol · Feb 7, 2022
Statistical analysis plan · Jun 3, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05325853
Lead sponsor: American Genomics, LLC
Responsible party: Sponsor
First posted: Apr 13, 2022
Start date: Apr 6, 2022
Primary completion: May 27, 2022
Completion: May 27, 2022
Results posted: Oct 25, 2023
Last update: Oct 25, 2023

Study contacts

Martin Uram, MD

study director · Medical Expert

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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