Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-01 @ 8:14 PM
Study NCT ID:
NCT04127851
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients
Sponsor:
Taejoon Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients
Status:
COMPLETED
Status Verified Date:
2019-10
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:
In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: