NCT03527212

A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease

A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients With Dry Eye Disease (DELTA-1 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Senju Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

Detailed description

There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	SJP-0035 0.001%	Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
DRUG	Placebo	Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks

Timeline

• Start date: 2018-08-20
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2018-05-17
• Last updated: 2019-04-16

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study