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

Phase 3

Not yet recruiting

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Hyalein Mini Drops; Drug: HUC3-053

• Registration Number: NCT06388070
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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.

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 Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyalein Mini Drops	Hyalein Mini Drops	Participants received "Hyalein Mini Drops" in each eye five to six times a day for 12 weeks.
HUC3-053	HUC3-053	Participants received "HUC3-053" drops in each eye five to six times a day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Corneal staining score	Week 12	Change from Baseline in Corneal staining score at week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gangbuk Samsung Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of