Dry Eye Syndromes
Conditions
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 Eye 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 Eye Drops given bilaterally five to six times a day. The treatment period is 12 weeks.
Interventions
DRUGHA 0.3%
Instillation in each eye five to six times a day for 12 weeks
DRUGHyalein Mini Eye Drops
Instillation in each eye five to six times a day for 12 weeks.
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Corneal staining score | Week 12 | Change from Baseline in Corneal staining score at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORChul Young Choi
Gangbuk Samsung Hospital
Outcome results
None listed