Study to Evaluate the Efficacy and Safety of CKD-350

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02777723
• Collaborator: (none)
• Enrollment: 138
• Locations: 14
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 9.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Xenobella; Drug: Isotonic 0.3% Sodium Hyaluronate	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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 Start Date: May 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CKD-350 Xenobella	Drug: Xenobella; Hypotonic 0.3% Sodium Hyaluronate; Other Names: Arm A
Active Comparator: Sodium Hyaluronate Isotonic 0.3% Sodium Hyaluronate	Drug: Isotonic 0.3% Sodium Hyaluronate; Isotonic 0.3% Sodium Hyaluronate; Other Names: Arm B

Outcome Measures

Primary Outcome Measures

1. Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 [Baseline, week 4]

Secondary Outcome Measures

1. Changes in Corneal Staining by Oxford scale from Baseline and at Week 2 [Baseline, week 2]

2. Changes in Tear Break-up Time from Baseline and at Week 2, 4 [Baseline, Week 2, 4]

3. Changes in Schirmer I Test from Baseline and at Week 2, 4 [Baseline, Week 2, 4]

4. Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 [Baseline, week 2, 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Hospital	Daejeon	Chungcheongnam-do	Korea, Republic of
2	Seoul National University Bundang Hospital	SeongNam	Gyeonggi-do	Korea, Republic of
3	Kyungpook National University Hospital	Daegu	Gyeongsangbuk-do	Korea, Republic of
4	Pusan National University Hospital	Busan	Gyeongsangnam-do	Korea, Republic of
5	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of
6	Chonnam National University Hospital	Gwangju	Jeollanam-do	Korea, Republic of
7	Asan Medical Center	Seoul		Korea, Republic of
8	Gangnam Severance Hospital	Seoul		Korea, Republic of
9	Korea University ANAM Hospital	Seoul		Korea, Republic of
10	Korea University GURO Hospital	Seoul		Korea, Republic of
11	Samsung Medical Center	Seoul		Korea, Republic of
12	Seoul National University Hospital	Seoul		Korea, Republic of
13	The Catholic University of Korea Seoul ST. MARY'S Hospital	Seoul		Korea, Republic of
14	Yonsei University Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Study Chair: HyoMyung Kim, MD, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT02777723
• Other Study ID Numbers: 164DES16001
• First Posted: May 19, 2016
• Last Update Posted: May 19, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Chong Kun Dang Pharmaceutical: Dry Eye Syndrome; Sodium Hyaluronate; CKD-350
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Hyaluronic Acid

Study Results

No Results Posted as of May 19, 2016