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

NCT ID: NCT06686368

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-03-31

Brief Summary

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

Detailed Description

Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye

Conditions

Evaporative Dry Eye Disease

Study Design

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

Study Groups

I-DROP MGD

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

Group Type: EXPERIMENTAL

I-DROP MGD

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Theloze Duo

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Systane Complete PF

Intervention Type: 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

Interventions

I-DROP MGD

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

Intervention Type: DEVICE

Theloze Duo

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

Intervention Type: DEVICE

Systane Complete PF

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

Intervention Type: DEVICE

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 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I-MED Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Karim Fahmy, Ph.D.

Role: CONTACT

kfahmy@imedpharma.com

1-800-463-1008

Other Identifiers

CR001-2024

Identifier Type: -

Identifier Source: org_study_id