Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye

Last updated: November 11, 2024
Sponsor: I-MED Pharma
Overall Status: Active - Not Recruiting

Phase

4

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eye Disease

Treatment

Theloze Duo

Systane Complete PF

I-DROP MGD

Clinical Study ID

NCT06686368
CR001-2024
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 tosevere 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

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 oculardisease 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 studyoutcome variable (e.g. uncontrolled autoimmune disease or uncontrolledimmunodeficiency 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 shouldrestrain their contact lens use to a very minimum during the study duration.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Theloze Duo
Phase: 4
Study Start date:
November 15, 2024
Estimated Completion Date:
March 31, 2025

Study 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