NCT06686368

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: I-MED Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-11-13
• Last updated: 2024-11-13