Dry Eye SyndromePhase 2NCT02092207
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
A Phase 2 study testing KL7016 900mg and KL7016 600mg in people with Dry Eye Syndrome, run by Yungjin Pharm. Co., Ltd. at 9 sites in South Korea.
Trial summary
This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- KL7016 900mg and KL7016 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Oct 2012to Jul 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
- Schirmer test score (without anesthesia) < 7 mm/5 min in either eye
- Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial
Who cannot join
- Intraocular surgery within 3months
- Persistent intraocular inflammation or infection
- Corneal transplantation or neurotrophic keratitis
- Stevens-Johnson Syndrome
- Ocular herpes simplex virus infection
- Concomitant use of contact lenses or use within 3months
Show all 9Show fewer
- Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months
- Vision correction surgery without DES within 12months
- Unstable use of methotrexate or Disease-modifying drugs
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Chonnam National University Hospital
Gwangju, Jebong-ro, Dong-gu, 501-757
Seoul National University Bundang Hospital
Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, 463-707
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Banpo-daero, Seocho-gu, 137-701
Gangnam Severance Hospital
Seoul, Eonju-ro, Gangnam-gu, 135-720
Korea University Guro Hospital
Seoul, Gurodong-ro, Guro-gu, 152-703
Samsung Medical Center
Seoul, Irwon-ro, Gangnam-gu, 135-710
Konkuk University Medical Center
Seoul, Neungdong-ro, Gwangjin-gu, 143-729
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, 120-752
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).
- Conditions
- Dry Eye Syndrome
- Being tested
- KL7016 900mg, KL7016 600mg, Placebo
- 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.
KL7016 900mgDrug
oral administration, 150mg 3tab, bid
KL7016 600mgDrug
oral administration, 150mg 3tab, bid
PlaceboDrug
oral administration, 150mg 3tab, bid
| Study group | Role | What they receive |
|---|---|---|
| KL7016 900mg | Experimental | Not described Receives: Drug: KL7016 900mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KL7016 600mg | Experimental | Not described Receives: Drug: KL7016 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal staining score
Measured: baseline, 12 weeks
Secondary outcomes (5)
Change in schirmer test score
Measured: baseline, 4weeks, 8weeks, 12 weeks
Change in OSDI(Ocular Surface Disease Index)
Measured: baseline, 4weeks, 8weeks, 12 weeks
Change in TFBUT(Tear Film Break-up Time)
Measured: baseline, 4weeks, 8weeks, 12 weeks
Change in conjunctival staining score
Measured: baseline, 4weeks, 8weeks, 12 weeks
Change in corneal staining score
Measured: baseline, 4weeks, 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJul 2014
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yungjin Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092207
- Sponsor's protocol ID
- KL7016_201
- Status last verified
- Dec 2017
- First submitted
- 17 Mar 2014
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02092207
- Acronym / sponsor ID
- KL7016_201
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Mar 2014 (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.
This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KL7016 900mg | Experimental | Drug: KL7016 900mg |
| Placebo | Placebo comparator | Drug: Placebo |
| KL7016 600mg | Experimental | Drug: KL7016 600mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
- Schirmer test score (without anesthesia) < 7 mm/5 min in either eye
- Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial
Key exclusion criteria (9 listed)
- Intraocular surgery within 3months
- Persistent intraocular inflammation or infection
- Corneal transplantation or neurotrophic keratitis
- Stevens-Johnson Syndrome
- Ocular herpes simplex virus infection
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 |
|---|---|---|
| KL7016 900mgoral administration, 150mg 3tab, bid | Drug | KL7016 900mg |
| KL7016 600mgoral administration, 150mg 3tab, bid | Drug | KL7016 600mg |
| Placebooral administration, 150mg 3tab, bid | Drug | Placebo |
Primary outcome
Change in corneal staining score
Time frame: baseline, 12 weeks
5 secondary outcomes
Change in schirmer test score
Time frame: baseline, 4weeks, 8weeks, 12 weeks
Change in OSDI(Ocular Surface Disease Index)
Time frame: baseline, 4weeks, 8weeks, 12 weeks
Change in TFBUT(Tear Film Break-up Time)
Time frame: baseline, 4weeks, 8weeks, 12 weeks
Change in conjunctival staining score
Time frame: baseline, 4weeks, 8weeks, 12 weeks
Change in corneal staining score
Time frame: baseline, 4weeks, 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KL7016 900mg and KL7016 600mg in people with Dry Eye Syndrome, run by Yungjin Pharm. Co., Ltd. at 9 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal staining score (time frame: baseline, 12 weeks). 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 21 Dec 2017.