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Not yet recruiting NCT06686368

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

Phase IV Interventional Evaporative Dry Eye Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: I-DROP MGD, Theloze Duo, Systane Complete PF.
Who it may be relevant to
Registry conditions: Evaporative Dry Eye Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial

Overview

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

Interventions

  • Device 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
  • 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
  • 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

Primary outcome measures

  • Fluorescein Tear Break-Up Time (FTBUT) in seconds [Time frame: Day 1 - 30 minutes post installation]
Secondary outcome measures (5)
  • Fluorescein Tear Break-Up Time (FTBUT) in seconds [Time frame: Day 7 - day 28]
  • Tear Meniscus Height (TMH) in milimiters [Time frame: Day 1 - Day 7 - day 28]
  • Osmolarity in mOsm/L [Time frame: Day 1 - Day 7 - day 28]
  • Number of Corneal and Conjunctival spots [Time frame: Day 7 - day 28]
  • Ocular Surface and Disease Index (OSDI) score [Time frame: Day 7 - day 28]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06686368 · CR001-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗