NCT06717152

Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease

A Randomized, Double-masked, Parallel, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of SJP-0132 Eye Drops Compared With Placebo in Chinese Patients With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of SJP-0132 in Chinese Patients with Dry Eye. Patients will be randomly assigned to receive either SJP-0132 or placebo.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	SJP-0132	Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group.
DRUG	Placebo	Aqueous eye drop, one drop each time and four times each day, 2 weeks in run-in period in both groups and 8 weeks in treatment period in placebo group.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-07-28
• Completion: 2025-09-01
• First posted: 2024-12-04
• Last updated: 2025-11-26

Locations

35 sites across 1 country: China