Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535947
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2020-08-27
Brief Title:
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease DED SDP-4-CS202
Sponsor:
Silk Technologies Ltd
Organization:
Silk Technologies Ltd
Study Overview
Official Title:
A Phase 2 Multicenter Double-Masked Randomized Vehicle-Controlled Parallel Group Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease DED
Status:
COMPLETED
Status Verified Date:
2021-05
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:
SDP-4-CS202 is a Phase 2 multicenter double-masked randomized vehicle-controlled parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period Once concentration 1 of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID
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