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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388070
• Other study ID #: HUC3-053
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Huons Co., Ltd.
• Contact: Hee Jung Yang
• Phone: +82-70-7492-6054
• Email: hjyang[@]huons.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• HUC3-053
drops in each eye five to six times a day for 12 weeks
• Hyalein Mini Drops
drops in each eye five to six times a day for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Corneal staining score	Change from Baseline in Corneal staining score at week 12	Week 12
Secondary	Change from Baseline in Corneal staining score	Change from Baseline in Corneal staining score at week 4, 8	Week 4, 8
Secondary	Change from Baseline in Conjunctival staining score	Change from Baseline in Conjunctival staining score at week 4, 8, 12	Week 4, 8, 12
Secondary	Change from Baseline in Schirmer test	Change from Baseline in Schirmer test at week 4, 8, 12	Week 4, 8, 12
Secondary	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
Secondary	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
Secondary	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