An Observational Study to Assess Optive MEGA-3 (OM3) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)

Study Identifier
P25-006
CT.gov Identifier
NCT06439394
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
  • Optive MEGA-3 (OM3)
    • 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 has at least one of the following signs 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 Screening Visit.
    Exclusion Criteria:
    * Use of artificial tears in the last 24 hours. * Use of more than 4 drops of artificial tears per day in each eye. * Use of dry eye treatment other than artificial tears.

    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 real-world experiences with Optive MEGA-3 (OM3) on relieving dry eye symptoms in adult participants with DED.

    OM3 is an over the counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of OM3 on Day 1 for the acute phase of the study, then 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
    Southern College of Optometry /ID# 262668
    Memphis, Tennessee, United States, 38104-2211
    Status
    Not applicable