I-DROP MGD Symptomatic Relief and Tear Film Stability

Examining Symptomatic Relief and Kinetic Stability of I-DROP MGD Eye Drops (LIME)

The objective of the study is to compare the difference in tear film stability and symptomatic relief between I-DROP MGD and another commercially available drop in the Canadian market.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: I-DROP MGD; Device: Thealoz Duo

Detailed Description

The purpose of this study is to:

• Compare tear film measurements for two hours after putting one drop of I-DROP MGD eye drops into one eye and one drop of Thealoz Duo eye drops in the other eye.
• Investigate the relief of dry eye symptoms with I-DROP MGD eye drops after 7 days of use.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education (CORE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Habitually uses ocular lubricants or artificial tears to relieve symptoms of dryness at least once per day for the past 30 days;

5. Has dry eye disease as per the TFOS DEWS II definition:

   1. DEQ-5 ≥ 6 or OSDI ≥ 13
   2. PLUS at least ONE of the following signs in at least one eye:

   i. NITBUT < 10 seconds ii. >5 spots of corneal fluorescein staining OR > 9 conjunctival spots iii. Lid wiper fluorescein staining ≥ 2mm length ≥ 25% width.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has worn any contact lenses in the past 30 days;
3. Has previously, or currently uses I-DROP MGD eye drops;
4. Has any known allergy or intolerance to I-DROP MGD or Thealoz Duo eye drops;
5. Has any known active* ocular disease (allergies or inflammation) and/or infection;
6. 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);
7. Has a history of sensitivity to rapidly blinking lights or photosensitive epilepsy as one of the a key assessment device employs rapid blinking lights;
8. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable (e.g. antihistamines);
9. Has known sensitivity to sodium fluorescein to be used in the study;
10. Self-reports that they are pregnant, lactating or planning a pregnancy at the time of enrolment;
11. Has a undergone ocular surgery in the past 6 months;
12. Uses warm compress therapy, unless performed regularly, for a minimum of 30 days, and maintained at the same frequency throughout the duration of the study;
13. Unwilling to stop using their habitual ocular lubricants or artificial tears after Visit 2 (start of Part II);
14. Has been fitted with punctal plugs within 30 days prior to Screening;
15. Is a member of the Centre for Ocular Research & Education directly involved in the study;

16. Has taken part in another clinical research study within the last 30 days.

    • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test (I-DROP MGD); Part I of this study is a contralateral eye design, accordingly patient would receive either I-DROP MGD (Test) or Thealoz Duo (Control) in either eye. Part II, patients shall receive either only I-DROP MGD	Device: I-DROP MGD; I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease.
Active Comparator: Control - Thealoz Duo; Part I of this study is a contralateral eye design, accordingly patient would receive either I-DROP MGD (Test) or Thealoz Duo (Control) in either eye. Part II, patients shall receive either only I-DROP MGD	Device: Thealoz Duo; I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 1 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 5 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 15 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 30 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 60 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 90 minutes after instillation
Non-Invasive Tear Break Up Time "NITBUT" duration	NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness	Part I: 120 minutes after instillation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Meniscus Height (TMH) Assessment	TMH assessment is measured in millimeters. TMH less than 0.2mm indicated eye dryness	Part I: 5-15-30-60-90-120 minutes after instillation
Lipid Layer Thickness (LLT) Assessment	LLT is assessed in nanometer. A LLT less than 100nm indicates eye dryness	Part I: 5-15-30-60-90-120 minutes after instillation
Ocular Surface Disease Index "OSDI" score	The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe eye dryness	(Part II: after 7 days of consecutive I-DROP MGD usage)
Standard Patient Evaluation of Eye Dryness Score "SPEED questionnaire"	SPEED questionnaire is assessed on a scale from 0 to 28. A higher composite score indicates more severe eye dryness	(Part II: after 7 days of consecutive I-DROP MGD usage)
Subjective measurement of "Change in comfort"	Participants will rate their eye comfort on a 0-100 scale, where 0=poor comfort, 100=excellent comfort	(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Subjective measurement of "Change in Dryness"	Participants will rate their eye dryness on a 0-100 scale, where 0=extremely dry, 100=no dryness	(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Subjective measurement of "Change in soothing"	Participants will rate their experience of soothing on a 0-100 scale, where 0=no soothing, 100=extremely soothing	(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Subjective measurement of "Change in quality of vision"	Participants will rate their quality of vision on a 0-100 scale, where 0=poor vision, 100=clear vision	(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)

Collaborators and Investigators

• Sponsor: I-MED Pharma
• Collaborators: University of Waterloo
• Investigators: Principal Investigator: Lyndon Jones, Ph.D., Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): January 12, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: IDROPMGD072021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No