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)

Study Identifier
P25-007
CT.gov Identifier
NCT06443775
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dry Eye
    • Study Drug
  • Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Saint Louis Eye Institute /ID# 263275
    Town and Country, Missouri, United States, 60025
    Status
    Not applicable