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Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

NCT06427031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2025-04-22

No results posted yet for this study

Summary

In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.

Conditions

  • Dry Eye
  • Dry Eye Syndromes

Interventions

DRUG

TJO-083

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

DRUG

Diquafosol ophthalmic sodium solution 3%

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Sponsors & Collaborators

  • Taejoon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2024-05-22
Completion
2024-07-03

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 NCT06427031 on ClinicalTrials.gov