CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 249 enrolled
Drug / intervention
AG-920 +1 moredrug
Likely dose
AG-920 Sterile Topical Ophthalmic SolutionAI-extracted
Key inclusion· 5
  • Male or non-pregnant, non-lactating female
  • Healthy by clinical assessment including ocular examination
  • Best corrected visual acuity (BCVA) of 20/200 or better in both eyes
  • Intraocular pressure (IOP) between 7 and 30 mmHg
Key exclusion· 11
  • Contraindication to local anesthetics, Septocaine, or any component of the investigational medicinal product
  • Ocular surgery or general surgery in either eye within the past 90 days
  • Intravitreal injection in either eye within 14 days of randomization
  • Ocular surface disease requiring punctal plugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05501860
NCT05501860Phase 3Completed

A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution

American Genomics, LLC·interventional·Posted Aug 16, 2022·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating AG-920 and Placebo for Anesthesia, Local. Completed, enrolled 249 participants across 2 sites.

Detailed Summary

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedAug 16, 2022
Enrollment StartJul 30, 2022
Primary CompletionDec 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.9 years ago

Interventions

AG-920drug

AG-920 Sterile Topical Ophthalmic Solution

Placebodrug

Placebo Sterile Topical Ophthalmic Solution