Study to Evaluate the Efficacy and Safety of CKD-350

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome

Detailed Description
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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

Official Title
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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

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Xenobella
* Drug: Isotonic 0.3% Sodium Hyaluronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than the age of 19 years old Subjects with dry eye symptoms for at least 3 month prior to screening 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 Subjects who have a visual acuity equal to or better than 0.2 in both eyes Subjects who sign on an informed consent form willingly Exclusion Criteria: Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 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 Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study Subjects who take steroidal or immunosuppressive drug within 1 month Over 22mmHg IOP(Intraocular Pressure) Subjects who have malignant tumor within 5 years Subjects with known hypersensitivity to investigational product Women who are nursing, pregnant or planning pregnancy during the study Subjects who have received any other investigational product within 1 month prior to the first dosing Impossible subjects who participate in clinical trial by investigator's decision

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-350<br>Xenobella | Drug: Xenobella<br>* Hypotonic 0.3% Sodium Hyaluronate<br>* Other names: Arm A;|
| Active Comparator: Sodium Hyaluronate<br>Isotonic 0.3% Sodium Hyaluronate | Drug: Isotonic 0.3% Sodium Hyaluronate<br>* Isotonic 0.3% Sodium Hyaluronate<br>* Other names: Arm B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 |  | Baseline, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndrome, Sodium Hyaluronate, CKD-350