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

American Genomics

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Local

Treatments: Drug: AG-920; Drug: Proparacaine Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05325853

AG-920-CS304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: Under 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

AG-920

Experimental group

Description:

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

Treatment:

Drug: AG-920

Proparacaine

Active Comparator group

Description:

0.5% Proparacaine Hydrochloride

Treatment:

Drug: Proparacaine Ophthalmic