Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747977
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2021-02-04
Brief Title:
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Sponsor:
Ocular Therapeutix Inc
Organization:
Ocular Therapeutix Inc
Study Overview
Official Title:
A Randomized Double-Masked Vehicle-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED Dexamethasone Intracanalicular Ophthalmic Insert for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease DED
Status:
COMPLETED
Status Verified Date:
2023-01
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:
To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease
Detailed Description:
Randomized double-masked vehicle-controlled phase 2 study evaluating the efficacy and safety of OTX-DED dexamethasone intracanalicular ophthalmic insert for the short-term treatment of signs and symptoms of Dry Eye Disease DED The subjects will be followed for approximately 2-3 months from screening to the last visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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