NCT04127851

Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients

A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Taejoon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug. Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.

Conditions

• Dry Eye
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	TJO-018 (HA 0.15%)	TJO-018 / one drop / 6 times daily in both eyes
DRUG	Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)	Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\~six times daily in both eyes
DRUG	TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%	TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-07-14
• Completion: 2021-10-14
• First posted: 2019-10-16
• Last updated: 2022-06-08

Locations

1 site across 1 country: South Korea