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

I-MED Pharma

Status and phase: Not yet enrolling; Phase 4

Conditions: Evaporative Dry Eye Disease

Treatments: Device: Theloze Duo; Device: Systane Complete PF; Device: I-DROP MGD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06686368

CR001-2024

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups

I-DROP MGD

Experimental group

Description:

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

Treatment:

Device: I-DROP MGD

Thealoz Duo

Active Comparator group

Description:

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

Treatment:

Device: Theloze Duo

Systane Complet PF

Active Comparator group

Description:

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

Treatment:

Device: Systane Complete PF