Clinical trial NCT06388070: To Evaluate the Efficacy and Safety of HUC3-053 in Patients with Dry Eye Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 280
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Corneal staining score
timeFrame: Week 12
Secondary outcomes:
measure: Change from Baseline in Corneal staining score
timeFrame: Week 4, 8
measure: Change from Baseline in Conjunctival staining score
timeFrame: Week 4, 8, 12
measure: Change from Baseline in Schirmer test
timeFrame: Week 4, 8, 12
measure: Change from Baseline in Tear film break-up time
timeFrame: Week 4, 8, 12
measure: Change from Baseline in Ocular surface disease index
timeFrame: Week 4, 8, 12
measure: Change from Baseline in Eye Soreness after eye drop assessed by NRS
timeFrame: Week 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangbuk Samsung Hospital
state: Jongno-gu
Study officials:
affiliation: Gangbuk Samsung Hospital
name: Chul Young Choi
role: PRINCIPAL_INVESTIGATOR
References: