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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- American Genomics, LLC
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.
Eligibility Criteria
- Ages
- — to 10 Years (Child)
- Sex
- 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
- •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.
Arms & Interventions
AG-920
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.
Intervention: AG-920 (Drug)
Proparacaine
0.5% Proparacaine Hydrochloride
Intervention: Proparacaine Ophthalmic (Drug)
Outcomes
Primary Outcomes
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
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From randomization through study completion (up to 4 days following treatment))