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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: AG-920
* Drug: Proparacaine Ophthalmic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AG-920<br>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<br>* AG-920 Sterile Topical Ophthalmic Solution<br>* Other names: articaine;|
| Active Comparator: Proparacaine<br>0.5% Proparacaine Hydrochloride | Drug: Proparacaine Ophthalmic<br>* 0.5% Proparacaine Hydrochloride<br>* Other names: Proparacaine;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AG-920, Articaine, Septocaine, Intravitreal Injection, Proparacaine