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Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

NCT05245604 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

TJO-087

Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily

DRUG

Cyclosporine ophthalmic solution 0.05%

Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Sponsors & Collaborators

  • Taejoon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hyo Myung Kim, MD, PhD · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2022-08-31
Completion
2023-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245604 on ClinicalTrials.gov