NCT06427031

Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Taejoon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.

Conditions

• Dry Eye
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	TJO-083	Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
DRUG	Diquafosol ophthalmic sodium solution 3%	Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Timeline

• Start date: 2023-07-14
• Primary completion: 2024-05-22
• Completion: 2024-07-03
• First posted: 2024-05-23
• Last updated: 2025-04-22

Locations

1 site across 1 country: South Korea