Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT02235259
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
Sponsor:
Xigen SA
Organization:
Study Overview
Official Title:
A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye
Status:
COMPLETED
Status Verified Date:
2016-07
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:
The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a Day (TID) treatment period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: