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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)

NCT06443775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2025-07-14

No results posted yet for this study

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

DRUG

Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)

Eye Drops

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2024-10-14
Completion
2024-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443775 on ClinicalTrials.gov