Study to Evaluate the Efficacy and Safety of CKD-350

Phase 3

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Isotonic 0.3% Sodium Hyaluronate; Drug: Xenobella

• Registration Number: NCT02777723
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-17
• Last Update Submitted: 2016-05-17
• Study First Posted: 2016-05-19
• Last Update Posted: 2016-05-19
• Primary Completion: 2016-07
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hyaluronate	Isotonic 0.3% Sodium Hyaluronate	Isotonic 0.3% Sodium Hyaluronate
CKD-350	Xenobella	Xenobella

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4	Baseline, week 4

Secondary Outcome Measures

Name	Time	Method
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
Changes in Tear Break-up Time from Baseline and at Week 2, 4	Baseline, Week 2, 4
Changes in Corneal Staining by Oxford scale from Baseline and at Week 2	Baseline, week 2

Trial Locations

Locations (14)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Seoul ST. MARY'S Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 SeongNam, Gyeonggi-do, Korea, Republic of

Korea University GURO Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Chungcheongnam-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of

Korea University ANAM Hospital; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Gyeongsangnam-do, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Jeollanam-do, Korea, Republic of