Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 7:07 AM
Study NCT ID:
NCT06792903
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CG-101 Eye Drops in the Treatment of Dry Eye Syndrome
Sponsor:
Eye & ENT Hospital of Fudan University
Organization:
Study Overview
Official Title:
Effectiveness and Safety of CG-101 Eye Drops in the Treatment of Dry Eye Syndrome
Status:
RECRUITING
Status Verified Date:
2025-01
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 study is a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of CG-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control.
Detailed Description:
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of CG-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control. The treatment period lasts for 84 days. Participants are randomly assigned to in randomized sequence.
There are three sequence, including sequence 1 (CG101 high dose in period 1 switch to placebo in period 2), sequence 2 (CG101 low dose in period 1 swich to CG101 high dose in period 2), and sequence 3 (placebo in period 1 swithc to CG101 high dose in period 2). Period 1 starts from 0W to 4W, then washout period lasts from 4W to 8W, and period 2 starts from 8W to 12W. Participant will need to visit the clinic at 2W, 4W 8W, 10W, 12W after enrollment for checkups and tests.
There are three sequence, including sequence 1 (CG101 high dose in period 1 switch to placebo in period 2), sequence 2 (CG101 low dose in period 1 swich to CG101 high dose in period 2), and sequence 3 (placebo in period 1 swithc to CG101 high dose in period 2). Period 1 starts from 0W to 4W, then washout period lasts from 4W to 8W, and period 2 starts from 8W to 12W. Participant will need to visit the clinic at 2W, 4W 8W, 10W, 12W after enrollment for checkups and tests.
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?:
False
Is an FDA AA801 Violation?: