A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients

NCT05245604 Phase 3 UNKNOWN

The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.

Details

Lead sponsor	Taejoon Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	182
Start date	2020-06-19
Completion	2023-04

Conditions

• Dry Eye Syndrome

Interventions

• TJO-087
• Cyclosporine ophthalmic solution 0.05%

Primary outcomes

• Change From Baseline in Non-anesthetic Schirmer Test at Week 32 — Baseline and Week 32
  The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Countries

South Korea