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I-DROP MGD Symptomatic Relief and Tear Film Stability

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
I-DROP MGD
Thealoz Duo
Sponsored by
I-MED Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Ocular Research & Education
  • Centre for Ocular Research & Education (CORE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test (I-DROP MGD)

Control - Thealoz Duo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Non-Invasive Tear Break Up Time "NITBUT" duration
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

Secondary Outcome Measures

Tear Meniscus Height (TMH) Assessment
TMH assessment is measured in millimeters. TMH less than 0.2mm indicated eye dryness
Lipid Layer Thickness (LLT) Assessment
LLT is assessed in nanometer. A LLT less than 100nm indicates eye dryness
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
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
Subjective measurement of "Change in comfort"
Participants will rate their eye comfort on a 0-100 scale, where 0=poor comfort, 100=excellent comfort
Subjective measurement of "Change in Dryness"
Participants will rate their eye dryness on a 0-100 scale, where 0=extremely dry, 100=no dryness
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
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

Full Information

First Posted
July 29, 2021
Last Updated
March 28, 2022
Sponsor
I-MED Pharma
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT05011708
Brief Title
I-DROP MGD Symptomatic Relief and Tear Film Stability
Official Title
Examining Symptomatic Relief and Kinetic Stability of I-DROP MGD Eye Drops (LIME)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-MED Pharma
Collaborators
University of Waterloo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Part 1 of the study will be double-masked (both investigator and participant are masked). Part 2 will not involve masking.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test (I-DROP MGD)
Arm Type
Experimental
Arm Description
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
Arm Title
Control - Thealoz Duo
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
I-DROP MGD
Intervention Description
I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease.
Intervention Type
Device
Intervention Name(s)
Thealoz Duo
Intervention Description
I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease.
Primary Outcome Measure Information:
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 1 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 5 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 15 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 30 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 60 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 90 minutes after instillation
Title
Non-Invasive Tear Break Up Time "NITBUT" duration
Description
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
Time Frame
Part I: 120 minutes after instillation
Secondary Outcome Measure Information:
Title
Tear Meniscus Height (TMH) Assessment
Description
TMH assessment is measured in millimeters. TMH less than 0.2mm indicated eye dryness
Time Frame
Part I: 5-15-30-60-90-120 minutes after instillation
Title
Lipid Layer Thickness (LLT) Assessment
Description
LLT is assessed in nanometer. A LLT less than 100nm indicates eye dryness
Time Frame
Part I: 5-15-30-60-90-120 minutes after instillation
Title
Ocular Surface Disease Index "OSDI" score
Description
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe eye dryness
Time Frame
(Part II: after 7 days of consecutive I-DROP MGD usage)
Title
Standard Patient Evaluation of Eye Dryness Score "SPEED questionnaire"
Description
SPEED questionnaire is assessed on a scale from 0 to 28. A higher composite score indicates more severe eye dryness
Time Frame
(Part II: after 7 days of consecutive I-DROP MGD usage)
Title
Subjective measurement of "Change in comfort"
Description
Participants will rate their eye comfort on a 0-100 scale, where 0=poor comfort, 100=excellent comfort
Time Frame
(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Title
Subjective measurement of "Change in Dryness"
Description
Participants will rate their eye dryness on a 0-100 scale, where 0=extremely dry, 100=no dryness
Time Frame
(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Title
Subjective measurement of "Change in soothing"
Description
Participants will rate their experience of soothing on a 0-100 scale, where 0=no soothing, 100=extremely soothing
Time Frame
(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)
Title
Subjective measurement of "Change in quality of vision"
Description
Participants will rate their quality of vision on a 0-100 scale, where 0=poor vision, 100=clear vision
Time Frame
(Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, Ph.D.
Organizational Affiliation
Centre for Ocular Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Ocular Research & Education
City
Toronto
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
Centre for Ocular Research & Education (CORE)
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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I-DROP MGD Symptomatic Relief and Tear Film Stability

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