Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye

NCT06686368 | Not Yet Recruiting Phase 4

• 1 other identifier: CR001-2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye

Conditions

Evaporative Dry Eye Disease

Keywords

Dry Eye Disease; Lubricant eye drops; Meibomian Gland Dysfunction; Evaporative dry eye

Outcome Measures

Primary Outcomes (1)

• Fluorescein Tear Break-Up Time (FTBUT) in seconds

  The primary outcome of the study is FBUT at 30 minutes post-installation

  Day 1 - 30 minutes post installation

Secondary Outcomes (5)

• Fluorescein Tear Break-Up Time (FTBUT) in seconds

  Day 7 - day 28

• Tear Meniscus Height (TMH) in milimiters

  Day 1 - Day 7 - day 28

• Osmolarity in mOsm/L

  Day 1 - Day 7 - day 28

• Number of Corneal and Conjunctival spots

  Day 7 - day 28

• Ocular Surface and Disease Index (OSDI) score

  Day 7 - day 28

Study Arms (3)

I-DROP MGD

EXPERIMENTAL

High Molecular weight hyaluronic acid + PC containing lubricant eye drop Receiving lubricant eye drops with high molecular weight hyaluronic acid

Device: I-DROP MGD

Thealoz Duo

ACTIVE COMPARATOR

Low Molecular weight hyaluronic acid + Trehalose containing lubricant eye dropReceiving lubricant eye drops with low molecular weight hyaluronic acid

Device: Theloze Duo

Systane Complet PF

ACTIVE COMPARATOR

No hyaluronic acid containing lubricant eye drop Receiving lubricant eye drops without hyaluronic acid

Device: Systane Complete PF

Interventions

I-DROP MGD DEVICE

All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30

I-DROP MGD

Theloze Duo DEVICE

All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30

Thealoz Duo

Systane Complete PF DEVICE

All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30

Systane Complet PF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 form.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
• OSDI ≥ 13
• And TBUT \< 10 seconds
• And \>5 spots of corneal fluorescein staining OR \> 9 conjunctival spots
• Meibomian Gland score of 1 or higher using NEI grading criteria.

You may not qualify if:

• Is participating in any concurrent clinical or research study.
• Is wears contact lenses.
• Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
• Has undergone eye surgery involving the cornea or conjunctiva.
• Aqueous deficient DED patients.
• Is currently or has used any of the study drops in the last 3 months.
• Has any known allergy or intolerance to any of the study drops.
• Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
• 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 known sensitivity to sodium fluorescein.
• Is pregnant, lactating or planning a pregnancy at the time of enrolment?
• Unwilling to stop using their habitual artificial tears for the study.
• Has been fitted with punctal plugs within 30 days before the study screening visit.
• Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.

Sponsors & Collaborators

• I-MED Pharma: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Central Study Contacts

Karim Fahmy, Ph.D.

CONTACT

1-800-463-1008; kfahmy@imedpharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All products will have their label removed and placed a white sticker showing the group (A or B or C). Products with be put in a white box with the letter indicated on it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: in vivo, human patient with confirmed Evaporative dry eye disease

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 13, 2024
• Study Start: November 15, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share