Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05865379
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-05-01
Brief Title:
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Sponsor:
TRB Chemedica International SA
Organization:
TRB Chemedica International SA
Study Overview
Official Title:
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease a Non-inferiority Investigation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
BUSTON-01
Brief Summary:
The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease The main questions it aims to answer are
Is BUFY01 non-inferior to SVS20 in terms of signs of DED
Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED
Participants will be asked to
Visit the trial site at 4 different timepoints
Use the allocated study treatment everyday until the end of the study during 3 months
Be examined by the investigator
Complete several questionnaires
Return unused study treatment
Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease together with comparable safety
Is BUFY01 non-inferior to SVS20 in terms of signs of DED
Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED
Participants will be asked to
Visit the trial site at 4 different timepoints
Use the allocated study treatment everyday until the end of the study during 3 months
Be examined by the investigator
Complete several questionnaires
Return unused study treatment
Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease together with comparable safety
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