Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-06-02 @ 7:52 AM
Study NCT ID:
NCT04324359
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
Sponsor:
Surface Ophthalmics, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
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:
SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.
The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
Detailed Description:
None
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?: