Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor … (NCT06686368) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye
60 participantsStarted 2024-11-15
Plain-language summary
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent form.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
* OSDI ≥ 13
* And TBUT \< 10 seconds
* And \>5 spots of corneal fluorescein staining OR \> 9 conjunctival spots
* Meibomian Gland score of 1 or higher using NEI grading criteria.
Exclusion Criteria:
* Is participating in any concurrent clinical or research study.
* Is wears contact lenses.
* Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
* Has undergone eye surgery involving the cornea or conjunctiva.
* Aqueous deficient DED patients.
* Is currently or has used any of the study drops in the last 3 months.
* Has any known allergy or intolerance to any of the study drops.
* Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease).
* Has known sensitivity to sodium flu…