I-DROP MGD Symptomatic Relief and Tear Film Stability

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dry Eye

Intervention / Treatment
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* Device: I-DROP MGD
* Device: Thealoz Duo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Habitually uses ocular lubricants or artificial tears to relieve symptoms of dryness at least once per day for the past 30 days; Has dry eye disease as per the TFOS DEWS II definition: DEQ-5 ≥ 6 or OSDI ≥ 13 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: Is participating in any concurrent clinical or research study; Has worn any contact lenses in the past 30 days; Has previously, or currently uses I-DROP MGD eye drops; Has any known allergy or intolerance to I-DROP MGD or Thealoz Duo eye drops; Has any known active* ocular disease (allergies or inflammation) and/or infection; 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 a history of sensitivity to rapidly blinking lights or photosensitive epilepsy as one of the a key assessment device employs rapid blinking lights; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable (e.g. antihistamines); Has known sensitivity to sodium fluorescein to be used in the study; Self-reports that they are pregnant, lactating or planning a pregnancy at the time of enrolment; Has a undergone ocular surgery in the past 6 months; 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; Unwilling to stop using their habitual ocular lubricants or artificial tears after Visit 2 (start of Part II); Has been fitted with punctal plugs within 30 days prior to Screening; Is a member of the Centre for Ocular Research & Education directly involved in the study; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test (I-DROP MGD)<br>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<br>* I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease.<br>|
| Active Comparator: Control - Thealoz Duo<br>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<br>* I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease.<br>|

What is the study measuring?
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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) |