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Dry EyeNCT05011708

I-DROP MGD Symptomatic Relief and Tear Film Stability

A study testing I-DROP MGD and Thealoz Duo in people with Dry Eye, run by I-MED Pharma at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
I-DROP MGD and Thealoz Duo
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesCanada
Study dates
23 Aug 2021to 12 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre for Ocular Research & Education

    Toronto, Ontario, N2L 3G1

  • Centre for Ocular Research & Education (CORE)

    Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Official title: 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.

Read the 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.
Conditions
Dry Eye
Being tested
I-DROP MGD, Thealoz Duo
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-DROP MGDDevice

    I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease.

  • Thealoz DuoDevice

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

Study groups in NCT05011708
Study groupRoleWhat they receive
Test (I-DROP MGD)ExperimentalPart 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
Receives: Device: I-DROP MGD
Control - Thealoz DuoActive comparatorPart 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
Receives: Device: Thealoz Duo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 1 minutes after instillation

  2. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 5 minutes after instillation

  3. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 15 minutes after instillation

  4. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 30 minutes after instillation

  5. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 60 minutes after instillation

  6. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 90 minutes after instillation

  7. Non-Invasive Tear Break Up Time "NITBUT" duration

    NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness

    Measured: Part I: 120 minutes after instillation

Secondary outcomes (8)

  1. Tear Meniscus Height (TMH) Assessment

    TMH assessment is measured in millimeters. TMH less than 0.2mm indicated eye dryness

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

  2. Lipid Layer Thickness (LLT) Assessment

    LLT is assessed in nanometer. A LLT less than 100nm indicates eye dryness

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

  3. 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

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

  4. 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

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

  5. Subjective measurement of "Change in comfort"

    Participants will rate their eye comfort on a 0-100 scale, where 0=poor comfort, 100=excellent comfort

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

  6. Subjective measurement of "Change in Dryness"

    Participants will rate their eye dryness on a 0-100 scale, where 0=extremely dry, 100=no dryness

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

  7. 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

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

  8. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start23 Aug 2021
  3. Primary completion15 Dec 2021
  4. Study completion12 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011708
Sponsor's protocol ID
IDROPMGD072021
Status last verified
Mar 2022
First submitted
29 Jul 2021
Last updated
29 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing I-DROP MGD and Thealoz Duo in people with Dry Eye, run by I-MED Pharma at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-Invasive Tear Break Up Time "NITBUT" duration (time frame: Part I: 1 minutes after instillation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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