NCT05017844

[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel Phase 2b/3 Study to Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Kukje Pharma · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	KSR-001-04	One drop to both eyes four times a day for 12 weeks
DRUG	KSR-001-02	One drop to both eyes four times a day for 12 weeks
DRUG	KSR-001-03	One drop to both eyes four times a day for 12 weeks

Timeline

• Start date: 2020-02-18
• Primary completion: 2021-02-08
• Completion: 2021-06-22
• First posted: 2021-08-24
• Last updated: 2021-08-24

Locations

1 site across 1 country: South Korea