Study to Evaluate the Efficacy and Safety of CKD-350

NCT02777723 | Unknown Phase 3

• 1 other identifier: 164DES16001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Dry Eye Syndrome

Keywords

Dry Eye Syndrome; Sodium Hyaluronate; CKD-350

Outcome Measures

Primary Outcomes (1)

• Changes in Corneal Staining by Oxford scale from Baseline and at Week 4

  Baseline, week 4

Secondary Outcomes (4)

• 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

Study Arms (2)

CKD-350

EXPERIMENTAL

Xenobella

Drug: Xenobella

Sodium Hyaluronate

ACTIVE COMPARATOR

Isotonic 0.3% Sodium Hyaluronate

Drug: Isotonic 0.3% Sodium Hyaluronate

Interventions

Xenobella DRUG

Hypotonic 0.3% Sodium Hyaluronate

Also known as: Arm A

CKD-350

Isotonic 0.3% Sodium Hyaluronate DRUG

Isotonic 0.3% Sodium Hyaluronate

Also known as: Arm B

Sodium Hyaluronate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (14)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, South Korea

RECRUITING

Pusan National University Hospital

Pusan, Gyeongsangnam-do, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, Jeollanam-do, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, Seoul, South Korea

NOT YET RECRUITING

Korea University ANAM Hospital

Seoul, Seoul, South Korea

RECRUITING

Korea University GURO Hospital

Seoul, Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

NOT YET RECRUITING

The Catholic University of Korea Seoul ST. MARY'S Hospital

Seoul, Seoul, South Korea

RECRUITING

Yonsei University Severance Hospital

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• HyoMyung Kim, MD

  Korea University Anam Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (14)