NCT06291194

Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	AJU-S56 5%	After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).
DRUG	Placebo Group(Vehicle)	After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Timeline

• Start date: 2023-11-10
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-03-04
• Last updated: 2024-04-08

Locations

1 site across 1 country: South Korea