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 | Completed FDA Drug

• 1 other identifier: P25-007
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Dry Eye; Next Generation Emulsion Preservative Free Eye Drops (NGE-UD); AGN-OPTIVEPLUS

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Ocular Surface Disease Index (OSDI) Score

  The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time to 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.

  Baseline to Day 15

• Change from Baseline in Current Symptom Score

  The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.'

  Baseline to Day 15

Study Arms (1)

NGE-UD

Participants will receive one drop of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Day 1, 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.

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

Interventions

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

Eye Drops

Also known as: Refresh Digital, Refresh Optive Advanced

NGE-UD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with dry eye disease and who are high digital device users.

You may qualify if:

• During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study.
• Participant with at least one sign of dry eye:
• Three consecutive tear break-up time (TBUT) tests \<= 10 seconds in at least one eye at Screening Visit OR;
• Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both at Screening Visit.
• Use of digital devices of 8 hours or more per day.
• Adult participants who answer yes to the following questions:
• Do you use digital devices at least 8 hours per day? Yes or No
• Are your eyes dry, irritated while using a digital screen like a computer or smartphone? Yes or No

You may not qualify if:

• Use of artificial tears in the last 24 hours.
• Current use of more than 4 drops of artificial tears per day in each eye.
• Use of dry eye treatment other than artificial tears.
• Are currently on ocular medications.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Saint Louis Eye Institute /ID# 263275

Town and Country, Missouri, 60025, United States

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 5, 2024
• Study Start: June 17, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)