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

Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Evaporative Dry Eye Disease
• Intervention / Treatment: Device: I-DROP MGD; Device: Theloze Duo; Device: Systane Complete PF

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karim Fahmy, Ph.D.; Phone Number: 1-800-463-1008; Email: kfahmy@imedpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-DROP MGD; High Molecular weight hyaluronic acid + PC containing lubricant eye drop Receiving lubricant eye drops with high molecular weight hyaluronic acid	Device: I-DROP MGD; All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
Active Comparator: Thealoz Duo; Low Molecular weight hyaluronic acid + Trehalose containing lubricant eye dropReceiving lubricant eye drops with low molecular weight hyaluronic acid	Device: Theloze Duo; All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
Active Comparator: Systane Complet PF; No hyaluronic acid containing lubricant eye drop Receiving lubricant eye drops without hyaluronic acid	Device: Systane Complete PF; All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: I-MED Pharma

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Meibomian Gland Dysfunction; Lubricant eye drops; Evaporative dry eye
• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CR001-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No