Study to Evaluate the Efficacy and Safety of CKD-350

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777723
• Other study ID #: 164DES16001
• Status: Recruiting
• Phase: Phase 3
• First received: May 15, 2016
• Last updated: May 17, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Xenobella
Hypotonic 0.3% Sodium Hyaluronate
• Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan	Gyeongsangnam-do
Korea, Republic of	Kyungpook National University Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	Chungnam National University Hospital	Daejeon	Chungcheongnam-do
Korea, Republic of	Chonnam National University Hospital	Gwangju	Jeollanam-do
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University ANAM Hospital	Seoul
Korea, Republic of	Korea University GURO Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul ST. MARY'S Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Corneal Staining by Oxford scale from Baseline and at Week 4		Baseline, week 4	No
Secondary	Changes in Corneal Staining by Oxford scale from Baseline and at Week 2		Baseline, week 2	No
Secondary	Changes in Tear Break-up Time from Baseline and at Week 2, 4		Baseline, Week 2, 4	No
Secondary	Changes in Schirmer I Test from Baseline and at Week 2, 4		Baseline, Week 2, 4	No
Secondary	Changes in Ocular Surface Disease Index from Baseline and at week 2, 4		Baseline, week 2, 4	No