Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375499
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Comparison of the Performance and Safety of T2769 Versus Hylo-Forte in the Treatment of Moderate to Severe Dry Eye Syndrome
Sponsor:
Laboratoires Thea
Organization:
Laboratoires Thea
Study Overview
Official Title:
Comparison of the Performance and Safety of T2769 Versus Hylo-Forte in the Treatment of Moderate to Severe Dry Eye Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte in terms of the change from baseline D1 in total ocular surface staining score assessed on Oxford 0-15 scale in the study eye at the D36 visit
The investigation is defined as a post-market stage The clinical investigation design is confirmatory
The investigation is defined as a post-market stage The clinical investigation design is confirmatory
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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