I-DROP MGD Symptomatic Relief and Tear Film Stability

NCT05011708 | Completed

• 1 other identifier: IDROPMGD072021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Tear Meniscus Height (TMH) Assessment

  Part I: 5-15-30-60-90-120 minutes after instillation

• Lipid Layer Thickness (LLT) Assessment

  Part I: 5-15-30-60-90-120 minutes after instillation

• Ocular Surface Disease Index "OSDI" score

  (Part II: after 7 days of consecutive I-DROP MGD usage)

• Standard Patient Evaluation of Eye Dryness Score "SPEED questionnaire"

  (Part II: after 7 days of consecutive I-DROP MGD usage)

• Subjective measurement of "Change in comfort"

  (Part II: At baseline and after 7 days of consecutive I-DROP MGD usage)

Study Arms (2)

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

Device: 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

Device: Thealoz Duo

Interventions

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.

Test (I-DROP MGD)

Thealoz Duo DEVICE

I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease.

Control - Thealoz Duo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• I-MED Pharma: lead
• University of Waterloo: collaborator

Study Sites (2)

Centre for Ocular Research & Education

Toronto, Ontario, N2L 3G1, Canada

Location

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Lyndon Jones, Ph.D.

  Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1 of the study will be double-masked (both investigator and participant are masked). Part 2 will not involve masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 18, 2021
• Study Start: August 23, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 12, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

CA (2)