Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443775
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-31
Brief Title:
An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops NGE-UD on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease DED
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops NGE-UD on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Dry Eye Disease DED is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication This study will evaluate Next Generation Emulsion Preservative Free Eye Drops NGE-UD in adult participants with dry eye symptoms and who are high digital device users
NGE-UD is an over-the-counter OTC monograph drug indicated for the temporary relief of symptoms of eye dryness Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15 Around 50 adult participants will be enrolled at one site in the United States
There is expected to be no additional burden for participants in this trial Study visits may be conducted on-site as per standard of care
NGE-UD is an over-the-counter OTC monograph drug indicated for the temporary relief of symptoms of eye dryness Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15 Around 50 adult participants will be enrolled at one site in the United States
There is expected to be no additional burden for participants in this trial Study visits may be conducted on-site as per standard of care
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?:
False
Is an FDA AA801 Violation?:
None