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To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome

NCT06388070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2026-03-05

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.

After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Eye Drops administered bilaterally five to six times a day for 12 weeks.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

HA 0.3%

Instillation in each eye five to six times a day for 12 weeks

DRUG

Hyalein Mini Eye Drops

Instillation in each eye five to six times a day for 12 weeks.

Sponsors & Collaborators

  • Huons Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chul Young Choi · Gangbuk Samsung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-03-14
Completion
2025-03-21

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 NCT06388070 on ClinicalTrials.gov