Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
138 participants
INTERVENTIONAL
2016-05-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of CKD-352
NCT04548427
Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease
NCT03888183
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
NCT01382225
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
NCT01135511
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
NCT01162954
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CKD-350
Xenobella
Xenobella
Hypotonic 0.3% Sodium Hyaluronate
Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xenobella
Hypotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
HyoMyung Kim, MD
Role: STUDY_CHAIR
Korea University Anam Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Pusan National University Hospital
Pusan, Gyeongsangnam-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chonnam National University Hospital
Gwangju, Jeollanam-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Gangnam Severance Hospital
Seoul, Seoul, South Korea
Korea University ANAM Hospital
Seoul, Seoul, South Korea
Korea University GURO Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
The Catholic University of Korea Seoul ST. MARY'S Hospital
Seoul, Seoul, South Korea
Yonsei University Severance Hospital
Seoul, Seoul, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
164DES16001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.