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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Male or female, age 20 or over

• Moderate to Severe Dry Eye Disease Patients

• Written informed consent to participate in the trial

Exclusion Criteria:

• Any laser or ocular surgery within 2 months prior screening

• Use of contact lenses

• Any condition limiting patient's ability to participate in the trial