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

Phase 4

Not yet recruiting

• Conditions: Evaporative Dry Eye Disease

• Registration Number: NCT06686368
• Lead Sponsor: I-MED Pharma

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

Study Timeline

• Study First Submitted: 2024-10-23
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Study Start: 2024-11-15
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fluorescein Tear Break-Up Time (FTBUT) in seconds	Day 1 - 30 minutes post installation	The primary outcome of the study is FBUT at 30 minutes post-installation

Secondary Outcome Measures

Name	Time	Method
Fluorescein Tear Break-Up Time (FTBUT) in seconds	Day 7 - day 28	One of the secondary endpoints is FTBUT at day 7 and day 28
Tear Meniscus Height (TMH) in milimiters	Day 1 - Day 7 - day 28	One of the secondary endpoints is TMH at day 1 (30 minutes post-installation), 7 and day 28
Osmolarity in mOsm/L	Day 1 - Day 7 - day 28	One of the secondary endpoints is osmolarity at day 1 (30 minutes post-installation), 7 and day 28
Number of Corneal and Conjunctival spots	Day 7 - day 28	One of the secondary endpoints is Corneal and conjunctival spots at day 7 and day 28
Ocular Surface and Disease Index (OSDI) score	Day 7 - day 28	One of the secondary endpoints is OSDI score at day 7 and day 28