I-DROP MGD Symptomatic Relief and Tear Film Stability

NCT ID: NCT05011708

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2022-01-12

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test (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

Group Type: EXPERIMENTAL

I-DROP MGD

Intervention Type: DEVICE

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

Control - Thealoz Duo

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

Group Type: ACTIVE_COMPARATOR

Thealoz Duo

Intervention Type: DEVICE

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

Interventions

I-DROP MGD

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

Intervention Type: DEVICE

Thealoz Duo

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

I-MED Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research and Education

Locations

Centre for Ocular Research & Education

Toronto, Ontario, Canada

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

IDROPMGD072021

Identifier Type: -

Identifier Source: org_study_id