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

A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome

This is a multi-center, randomized, double-blinded, non-inferiority study to evluate 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 Drops administered bilaterally five to six times a day for 12 weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: HUC3-053; Drug: Hyalein Mini Drops

Detailed Description

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

During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Drops given bilaterally five to six times a day. The treatment period is 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hee Jung Yang; Phone Number: +82-70-7492-6054; Email: hjyang@huons.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HUC3-053; Participants received "HUC3-053" drops in each eye five to six times a day for 12 weeks.	Drug: HUC3-053; drops in each eye five to six times a day for 12 weeks; Other Names: Kynex 3 eye drops
Active Comparator: Hyalein Mini Drops; Participants received "Hyalein Mini Drops" in each eye five to six times a day for 12 weeks.	Drug: Hyalein Mini Drops; drops in each eye five to six times a day for 12 weeks.; Other Names: Hyalein Mini Drops 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Corneal staining score	Change from Baseline in Corneal staining score at week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Corneal staining score	Change from Baseline in Corneal staining score at week 4, 8	Week 4, 8
Change from Baseline in Conjunctival staining score	Change from Baseline in Conjunctival staining score at week 4, 8, 12	Week 4, 8, 12
Change from Baseline in Schirmer test	Change from Baseline in Schirmer test at week 4, 8, 12	Week 4, 8, 12
Change from Baseline in Tear film break-up time	Change from Baseline in Tear film break-up time at week 4, 8, 12	Week 4, 8, 12
Change from Baseline in Ocular surface disease index	Change from Baseline in Ocular surface disease index at week 4, 8, 12	Week 4, 8, 12
Change from Baseline in Soreness after eye drop assessed by NRS	Change from Baseline in Soreness after eye drop assessed by NRS at week 4, 8, 12	Week 4, 8, 12

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.
• Investigators: Principal Investigator: Chul Young Choi, Gangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: HUC3-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No