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

AG-920-CS304

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.

2022-04-06

2022-05-27

2022-05-27

Completed

Early phase I

61

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}

2023-10-25