Clinical trial 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: Dry Eye
Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
AGN-OPTIVEPLUS
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with dry eye disease and who are high digital device users.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Ocular Surface Disease Index (OSDI) Score
timeFrame: Baseline to Day 15
measure: Change from Baseline in Current Symptom Score
timeFrame: Baseline to Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Town And Country
country: United States
facility: Saint Louis Eye Institute /ID# 263275
state: Missouri
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: