Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513652
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2020-08-09
Brief Title:
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Sponsor:
American Genomics LLC
Organization:
American Genomics LLC
Study Overview
Official Title:
A Randomized Double-Masked Vehicle-Controlled Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 randomized placebo-controlled double masked parallel design study in healthy subjects performed in the US It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution
Detailed Description:
This is a Phase 3 randomized placebo-controlled double masked parallel design study in healthy subjects performed in the US It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution In this study subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 11 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None