Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444516
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-31
Brief Title:
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease DED
Detailed Description:
The study will consist of a Screening visit a Baseline visit on Day 1 a remote Compliance Check on Day 14 and an Exit visit on Day 30 The expected study duration of participation for each subject is 37 days with 30 5 days of exposure to the investigational product
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