MedTrace Logo

Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

NCT06291194 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2024-04-08

No results posted yet for this study

Summary

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Placebo Group(Vehicle)

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

DRUG

AJU-S56 5%

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Sponsors & Collaborators

  • GL Pharm Tech Corporation

    collaborator INDUSTRY

  • AJU Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT06291194 on ClinicalTrials.gov