Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520202
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
RHPRG4 FOR THE TREATMENT OF SJÖGRENS RELATED DRY EYE DISEASE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE II PROSPECTIVE RANDOMIZED CROSSOVER STUDY ASSESSING THE ACUTE SAFETY EFFICACY OF RHPRG4 450 µGML RECOMBINANT HUMAN PROTEOGLYCAN 4 COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGRENS RELATED DRY EYE DISEASE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 1-day randomized 11 controlled masked pre-market study Subjects with moderate to severe Sjögrens related Dry Eye Disease will be evaluated at 0 5 30 90 minutes post dose of either rhPRG4 Treatment group or vehicle Crossover group At 90 minutes Crossover group subjects will be administered rhPRG4 then evaluated 5 30 minutes after rhPRG4 instillation 95 120 minutes from baseline All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None