drugset / Trial / NCT04127851

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

NCT04127851

Phase 4 Completed 438 enrolled Taejoon Pharmaceutical Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-11-12
Primary completion
2021-07-14
Completion
2021-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 0.05 % Other
Subject TJO-018 Unknown 0.15 % Other
Comparator Carboxymethylcellulose Other / unclassified 0.5 % Other

Indications