NCT06435182

Study of OT202 in Treating Moderate to Severe Dry Eye

A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to explore the optimal dosage of OT202 in treating dry eye.

Detailed description

Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops, treated with OT202 three times daily (morning, afternoon, and evening), with 1-2 drops each time. On the day of the baseline visit (Visit 2), subjects will be assessed again to meet the inclusion and exclusion criteria. Subjects remain in the study are then randomized with a 1:1:1 ratio to 3 groups, the 0.5% OT202 eye drop group, 1% OT202 eye drop group, or OT202 solvent eye drop group, for an 8-week treatment period. Safety visits will be conducted 2 weeks after completion of the respective treatment.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	OT202 conc 0.5%	Apply 1-2 drops of OT202 0.5% solution into the conjunctival sac. three times daily
DRUG	OT202 conc 0.1%	Apply 1-2 drops of OT202 0.1% solution into the conjunctival sac. three times daily
DRUG	Placebo	Apply 1-2 drops of placebo solution into the conjunctival sac. three times daily

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2024-05-30
• Last updated: 2024-05-30

Locations

10 sites across 1 country: China