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

NCT06686368 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • I-MED Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-03-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686368 on ClinicalTrials.gov