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.
Study Type
OBSERVATIONAL
Enrollment
47
Saint Louis Eye Institute /ID# 263275
Town and Country, Missouri, United States
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.
Time frame: 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.'
Time frame: Baseline to Day 15
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