Clinical trial NCT06686368: Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye
Official title: Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Evaporative Dry Eye Disease
Keywords: Dry Eye Disease
Lubricant eye drops
Meibomian Gland Dysfunction
Evaporative dry eye
Lead sponsor: I-MED Pharma
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: in vivo, human patient with confirmed Evaporative dry eye disease
Primary purpose: TREATMENT

Brief summary: A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye

Detailed description: Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye

Eligibility criteria: 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 fluorescein.
* Is pregnant, lactating or planning a pregnancy at the time of enrolment?
* Unwilling to stop using their habitual artificial tears for the study.
* Has been fitted with punctal plugs within 30 days before the study screening visit.
* Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.

Primary outcomes:
measure: Fluorescein Tear Break-Up Time (FTBUT) in seconds
timeFrame: Day 1 - 30 minutes post installation
Secondary outcomes:
measure: Fluorescein Tear Break-Up Time (FTBUT) in seconds
timeFrame: Day 7 - day 28
measure: Tear Meniscus Height (TMH) in milimiters
timeFrame: Day 1 - Day 7 - day 28
measure: Osmolarity in mOsm/L
timeFrame: Day 1 - Day 7 - day 28
measure: Number of Corneal and Conjunctival spots
timeFrame: Day 7 - day 28
measure: Ocular Surface and Disease Index (OSDI) score
timeFrame: Day 7 - day 28
Other outcomes:
Locations:
Study officials:
References: