Dry Eye SyndromePhase 3NCT02777723
Study to Evaluate the Efficacy and Safety of CKD-350
A Phase 3 study testing Xenobella and Isotonic 0.3% Sodium Hyaluronate in people with Dry Eye Syndrome, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Xenobella and Isotonic 0.3% Sodium Hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 14 sitesSouth Korea
- Study dates
- May 2016to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites, 14 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do
HongKyun Kim, MD, 82-10-4509-4886, okeye@knu.ac.kr
- Not yet recruiting
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
SiHwan Choi, MD, 82-10-5427-7609, shchoi@cnu.ac.kr
- Recruiting
Chonnam National University Hospital
Gwangju, Jeollanam-do
KyungChul Yoon, MD, 82-10-9220-0234, kcyoon@chonnam.ac.kr
- Recruiting
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
InChun You, MD, 82-10-3292-1824, you2ic@hanmail.net
- Recruiting
Pusan National University Hospital
Pusan, Gyeongsangnam-do
JongSu Lee, MD, 82-10-9021-2498, jongsool@pusan.ac.kr
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
JoonYoung Hyon, MD, 82-10-2735-8123, jyhyon@snu.ac.kr
- Recruiting
Asan Medical Center
Seoul, Seoul
HungWon Tchah, MD, 82-10-8177-8000, hwtchah@amc.seoul.kr
- Not yet recruiting
Gangnam Severance Hospital
Seoul, Seoul
HyungKeun Lee, MD, 82-10-6202-7164, shadik@yumc.yonsei.ac.kr
- Recruiting
Korea University ANAM Hospital
Seoul, Seoul
HyoMyoung Kim, MD, 82-10-5415-5776, hyomkim@daum.net
- Recruiting
Korea University GURO Hospital
Seoul, Seoul
JongSeok Song, MD, 82-10-9494-1606, song1606@gmail.com
- Recruiting
Samsung Medical Center
Seoul, Seoul
TaeYoung Chung, MD, 82-10-9933-3563, tychung@skku.edu
- Not yet recruiting
Seoul National University Hospital
Seoul, Seoul
MeeKum Kim, MD, 82-10-6277-0798, kmk9@snu.ac.kr
- Recruiting
The Catholic University of Korea Seoul ST. MARY'S Hospital
Seoul, Seoul
SoHyang Chung, MD, 82-10-6313-6202, chungsh@catholic.ac.kr
- Recruiting
Yonsei University Severance Hospital
Seoul, Seoul
TaeIm Kim, MD, 82-10-6309-9639, tikim@yumc.yonsei.ac.kr
About this study
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
The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome
Read the 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
- Conditions
- Dry Eye Syndrome
- Being tested
- Xenobella, Isotonic 0.3% Sodium Hyaluronate
- Keywords
- Dry Eye Syndrome, Sodium Hyaluronate, CKD-350
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenobellaDrug
Also called Arm A
Hypotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium HyaluronateDrug
Also called Arm B
Isotonic 0.3% Sodium Hyaluronate
| Study group | Role | What they receive |
|---|---|---|
| CKD-350 | Experimental | Xenobella Receives: Drug: Xenobella |
| Sodium Hyaluronate | Active comparator | Isotonic 0.3% Sodium Hyaluronate Receives: Drug: Isotonic 0.3% Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
Measured: Baseline, week 4
Secondary outcomes (4)
Changes in Corneal Staining by Oxford scale from Baseline and at Week 2
Measured: Baseline, week 2
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Measured: Baseline, Week 2, 4
Changes in Schirmer I Test from Baseline and at Week 2, 4
Measured: Baseline, Week 2, 4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Measured: Baseline, week 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HyoMyung Kim, MD, Study chair, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777723
- Sponsor's protocol ID
- 164DES16001
- Status last verified
- May 2016
- First submitted
- 15 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02777723
- Acronym / sponsor ID
- 164DES16001
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome, Sodium Hyaluronate, CKD-350
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-350 | Experimental | Drug: XenobellaXenobella |
| Sodium Hyaluronate | Active comparator | Drug: Isotonic 0.3% Sodium HyaluronateIsotonic 0.3% Sodium Hyaluronate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenobellaAlso: Arm AHypotonic 0.3% Sodium Hyaluronate | Drug | CKD-350 |
| Isotonic 0.3% Sodium HyaluronateAlso: Arm BIsotonic 0.3% Sodium Hyaluronate | Drug | Sodium Hyaluronate |
Primary outcome
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
Time frame: Baseline, week 4
4 secondary outcomes
Changes in Corneal Staining by Oxford scale from Baseline and at Week 2
Time frame: Baseline, week 2
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Time frame: Baseline, Week 2, 4
Changes in Schirmer I Test from Baseline and at Week 2, 4
Time frame: Baseline, Week 2, 4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Time frame: Baseline, week 2, 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HyoMyung Kim, MD study chair
Korea University Anam Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenobella and Isotonic 0.3% Sodium Hyaluronate in people with Dry Eye Syndrome, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.