Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734197
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-01-28
Brief Title:
A Research Study To See How Well an Eye Drop SURF-100 A Mycophenolic AcidBetamethasone Sodium Phosphate Combination Works and What Side Effects There Are in Subjects With Dry Eye Disease
Sponsor:
Surface Ophthalmics Inc
Organization:
Surface Ophthalmics Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Masked Study To Evaluate The Safety Tolerability And Efficacy Of SURF-100 Ophthalmic Solution A Mycophenolic AcidBetamethasone Sodium Phosphate Combination In Subjects With Dry Eye Disease
Status:
COMPLETED
Status Verified Date:
2023-02
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-100 is being studied for the treatment of dry eye disease SURF-100 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-100 works to treat dry eye and what potential side effects there are and to compare it with Vehicle placebo 01 mycophenolic acid MPA in Vehicle 03 MPA in Vehicle 001 betamethasone phosphate BSP in Vehicle Restasis and Xiidra This study will involve about 280-350 study participants age 18 and older at about 40 different research sites in the United States
The purpose of this research study is to see how well SURF-100 works to treat dry eye and what potential side effects there are and to compare it with Vehicle placebo 01 mycophenolic acid MPA in Vehicle 03 MPA in Vehicle 001 betamethasone phosphate BSP in Vehicle Restasis and Xiidra This study will involve about 280-350 study participants age 18 and older at about 40 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?:
None