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

Huons

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: HUC3-053; Drug: Hyalein Mini Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT06388070

HUC3-053

Details and patient eligibility

About

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 Drops administered bilaterally five to six times a day for 12 weeks.

Full description

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.

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

HUC3-053

Experimental group

Description:

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

Treatment:

Drug: HUC3-053

Hyalein Mini Drops

Active Comparator group

Description:

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

Treatment:

Drug: Hyalein Mini Drops