Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835623
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2021-04-05
Brief Title:
CEQUA for Sjogrens Syndrome Dry Eye
Sponsor:
Center for Ophthalmic and Vision Research LLC
Organization:
Center for Ophthalmic and Vision Research LLC
Study Overview
Official Title:
Effects of CEQUA on Objective and Subjective Dry Eye Findings Associated With Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The primary objective of this study is to show that CEQUA cyclosporine 009 ophthalmic solution improves symptoms of dry eye disease in a population of patients with Sjogrens Syndrome diagnosis
Detailed Description:
After being informed about the study and potential risks all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study Eligible participants will continue to the second visit the same day or up to 10 days later During the second visit participants will answer questionnaires about their eyes and have their vision eyes and tears examined All participants will be given CEQUA to use over the duration of the study The same procedures will be repeated every four weeks for 3 months total
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?:
False
Is an FDA AA801 Violation?:
None