NCT06443775

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)

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)	Eye Drops

Timeline

• Start date: 2024-06-17
• Primary completion: 2024-10-14
• Completion: 2024-10-14
• First posted: 2024-06-05
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study