NCT06792903

YM-101 Eye Drops in the Treatment of Dry Eye Syndrome

Effectiveness and Safety of YM-101 Eye Drops in the Treatment of Dry Eye Syndrome

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of YM-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control.

Detailed description

This study is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of YM-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control. The treatment period lasts for 84 days. Participants are randomly assigned to in randomized sequence. There are three sequence, including sequence 1 (YM-101 high dose in period 1 switch to placebo in period 2), sequence 2 (YM-101 low dose in period 1 swich to YM-101 high dose in period 2), and sequence 3 (placebo in period 1 switch to YM-101 high dose in period 2). Period 1 starts from 0W to 4W, then washout period lasts from 4W to 8W, and period 2 starts from 8W to 12W. Participant will need to visit the clinic at 2W, 4W 8W, 10W, 12W after enrollment for checkups and tests.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	YM-101 high dose + artificial tear	Patient in this group received high dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive placebo YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.
DRUG	YM-101 low dose + artificial tear	Patient in this group received low dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive high dose YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.
DRUG	placebo + artificial tear	Patient in this group received placebo dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive low dose YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.

Timeline

• Start date: 2024-04-23
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2025-01-27
• Last updated: 2026-03-16

Locations

1 site across 1 country: China