Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388070
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-10
Brief Title:
To Evaluate the Efficacy and Safety of HUC3-053 in Patients with Dry Eye Syndrome
Sponsor:
Huons Co Ltd
Organization:
Huons Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blinded Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared with Hyalein Mini Eye Drops in Patients with Dry Eye Syndrome
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This is a multi-center randomized double-blinded non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome
After a 2-week run-in period patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks
After a 2-week run-in period patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks
Detailed Description:
This is a multi-center randomized double-blinded non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome
During a 2-week study run-in period prior to randomization all subjects will receive rescue drug bilaterally up to 4 times a day Randomization will then occur as 11 where patients will be assigned to receive HUC3-053 or Hyalein Mini Drops given bilaterally five to six times a day The treatment period is 12 weeks
During a 2-week study run-in period prior to randomization all subjects will receive rescue drug bilaterally up to 4 times a day Randomization will then occur as 11 where patients will be assigned to receive HUC3-053 or Hyalein Mini Drops given bilaterally five to six times a day The treatment period is 12 weeks
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