NCT04139122

Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

A Randomized, Double-Masked, Single-Center, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of SJP-0132 in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Senju Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease

Conditions

• Dry Eye Disease
• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	SJP-0132	SJP-0132 is administered as an eye drop
DRUG	Placebo	Placebo is administered as an eye drop

Timeline

• Start date: 2019-10-05
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2019-10-25
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study