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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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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.
The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (I-DROP MGD) | Experimental | 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 |
|
| Control - Thealoz Duo | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-DROP MGD | Device | I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease. |
|
| 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 |
| 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 |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, Ph.D. | Centre for Ocular Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Toronto | Ontario | N2L 3G1 | Canada | ||
| Centre for Ocular Research & Education (CORE) |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Part 1 of the study will be double-masked (both investigator and participant are masked).
Part 2 will not involve masking.
| Thealoz Duo | Device | I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease. |
|
| Part I: 120 minutes after instillation |
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) |
| Waterloo |
| Ontario |
| N2L 3G1 |
| Canada |