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

NCT06388070 | Completed Phase 3

• 1 other identifier: HUC3-053
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Corneal staining score

  Change from Baseline in Corneal staining score at week 12

  Week 12

Secondary Outcomes (6)

• Change from Baseline in Corneal staining score

  Week 4, 8

• Change from Baseline in Conjunctival staining score

  Week 4, 8, 12

• Change from Baseline in Schirmer test

  Week 4, 8, 12

• Change from Baseline in Tear film break-up time

  Week 4, 8, 12

• Change from Baseline in Ocular surface disease index

  Week 4, 8, 12

Study Arms (2)

HUC3-053

EXPERIMENTAL

Participants received "HUC3-053" in each eye five to six times a day for 12 weeks.

Drug: HA 0.3%

Hyalein Mini Eye Drops

ACTIVE COMPARATOR

Participants received "Hyalein Mini Eye Drops" in each eye five to six times a day for 12 weeks.

Drug: Hyalein Mini Eye Drops

Interventions

HA 0.3% DRUG

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

HUC3-053

Hyalein Mini Eye Drops DRUG

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

Also known as: Hyalein Mini 0.3%

Hyalein Mini Eye Drops

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 19
• Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
• Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
• Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit

You may not qualify if:

• The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
• SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9%
• Wearing contact lenses within 72 hr of screening visit
• Pregnancy or Breastfeeding

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Gangbuk Samsung Hospital

Seoul, Jongno-gu, 03181, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Chul Young Choi

  Gangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 29, 2024
• Study Start: May 20, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 21, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

KR (1)