Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262100
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-01-31
Brief Title:
Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye
Sponsor:
Marinomed Biotech AG
Organization:
Marinomed Biotech AG
Study Overview
Official Title:
Clinical Investigation to Evaluate the Lubricating Performance of Carragelose Containing Eye Drops in Patients Diagnosed With Mild-to-moderate Dry Eye Disease
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Patients suffering from dry eye syndrom will treat their eyes with Carragelose eye drops three times a day for 28 days Before in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist Differences between before and after treatment will be assessed
Detailed Description:
The objective is to evaluate the safety and performance of Carragelose-containing eye drops in treating symptoms and signs of dry eye syndrom
Patients will treat their eyes with one eye drop three times a day for 28 days Baseline assessment will be performed after normal controlled environment and after adverse controlled environment At the end of investigation ocular symptoms and ocular sign will be assessed after normal controlled environment and after adverse controlled environment Differences between baseline and end of investigation will be evaluated for efficacy analysis
Patients will treat their eyes with one eye drop three times a day for 28 days Baseline assessment will be performed after normal controlled environment and after adverse controlled environment At the end of investigation ocular symptoms and ocular sign will be assessed after normal controlled environment and after adverse controlled environment Differences between baseline and end of investigation will be evaluated for efficacy analysis
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