Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome, Sodium Hyaluronate, CKD-350
Brief summary
The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome
Detailed description
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome
Interventions
DRUGXenobella
Hypotonic 0.3% Sodium Hyaluronate
DRUGIsotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. More than the age of 19 years old 2. Subjects with dry eye symptoms for at least 3 month prior to screening 3. Subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of Tear Break-up Time 3) ≤10mm/5min of Schirmer I Test 4. Subjects who have a visual acuity equal to or better than 0.2 in both eyes 5. Subjects who sign on an informed consent form willingly
Exclusion criteria
1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 2. Subjects who have medical history following 1) Abnormal eyelids function including abnormality of eyelid or eyelash 2) Ophthalmology operation within 1 year 3) Active ocular infection at present or treatment of allergic eye diseases 4) Herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus 3. Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial 4. Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study 5. Subjects who take steroidal or immunosuppressive drug within 1 month 6. Over 22mmHg IOP(Intraocular Pressure) 7. Subjects who have malignant tumor within 5 years 8. Subjects with known hypersensitivity to investigational product 9. Women who are nursing, pregnant or planning pregnancy during the study 10. Subjects who have received any other investigational product within 1 month prior to the first dosing 11. Impossible subjects who participate in clinical trial by investigator's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 | Baseline, week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Corneal Staining by Oxford scale from Baseline and at Week 2 | Baseline, week 2 |
| Changes in Tear Break-up Time from Baseline and at Week 2, 4 | Baseline, Week 2, 4 |
| Changes in Schirmer I Test from Baseline and at Week 2, 4 | Baseline, Week 2, 4 |
| Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 | Baseline, week 2, 4 |
Countries
South Korea
Outcome results
None listed