Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435182
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-05-20
Brief Title:
Study of OT202 in Treating Moderate to Severe Dry Eye
Sponsor:
Ocumension Therapeutics Shanghai Co Ltd
Organization:
Ocumension Therapeutics Suzhou Co Ltd
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
This is a phase II study to explore the optimal dosage of OT202 in treating dry eye
Detailed Description:
Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops treated with OT202 three times daily morning afternoon and evening with 1-2 drops each time On the day of the baseline visit Visit 2 subjects will be assessed again to meet the inclusion and exclusion criteria Subjects remain in the study are then randomized with a 111 ratio to 3 groups the 05 OT202 eye drop group 1 OT202 eye drop group or OT202 solvent eye drop group for an 8-week treatment period Safety visits will be conducted 2 weeks after completion of the respective treatment
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