Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-28 @ 1:05 AM
Study NCT ID:
NCT07068958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Sponsor:
ORA, Inc.
Organization:
Study Overview
Official Title:
A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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 evaluate the safety and efficacy of 0.25% RCI001 Ophthalmic Solution twice a day (BID) and four times a day (QID) compared to placebo (vehicle) in the treatment of the signs and symptoms of dry eye.
The secondary objective of this study is to evaluate the optimal dosing frequency of 0.25% RCI001 Ophthalmic Solution (BID versus QID) in the treatment of the signs and symptoms of dry eye.
The secondary objective of this study is to evaluate the optimal dosing frequency of 0.25% RCI001 Ophthalmic Solution (BID versus QID) in the treatment of the signs and symptoms of dry eye.
Detailed Description:
None
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?: