Dry Eye SyndromesPhase 3NCT01804361
Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
A Phase 3 study testing Haporine-S and Restasis (cyclosporine 0.05%) in people with Dry Eye Syndromes, run by DH Bio Co., Ltd. at 6 sites in South Korea.
Trial summary
The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Haporine-S and Restasis (cyclosporine 0.05%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Mar 2013to Feb 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 20 or over
- Patients with moderate to severe dry eye(DEWS Level II or over)
- Be informed of the nature of the study and will give written informed consent
Who cannot join
- Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
- Being treated with systemic steroid or immunosuppressive
- History of eyeball surgical operation within 6 months
- Wearing contact lenses during participation of the study
- Pregnancy or breastfeeding
- Use of cyclosporine eye drop within 2 weeks
Show all 10Show fewer
- Intraocular pressure(IOP)> 25 mmHg
- History of punctal occlusion within 1 month or during participation of the study
- Hypersensitivity to the investigational products or be suspicious to them
- Patients whom the investigator considers inappropriate to participate in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Busan National University Hospital
Busan, Busan, 602-739
Seoul National University Hospital
Seoul, Seoul, 110-744
Yonsei University Gangnam Severance Hospital
Seoul, Seoul, 135-720
Korea University Anam Hospital
Seoul, Seoul, 136-705
Asan Medical Center
Seoul, Seoul, 138-736
Korea University Guro Hospital
Seoul, Seoul, 152-703
About this study
Official title: Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial
The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.
Read the detailed description
This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.
Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
- Conditions
- Dry Eye Syndromes
- Being tested
- Haporine-S, Restasis (cyclosporine 0.05%)
- Keywords
- Dry Eye Syndromes
- 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.
Haporine-SDrug
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Restasis (cyclosporine 0.05%)Drug
1 or 2 drops twice a day at 12 hour interval for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Haporine-S | Experimental | Moderate to severe dry patients administered with with Haporine-S Receives: Drug: Haporine-S |
| Restasis, Cyclosporine 0.05% | Active comparator | Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%) Receives: Drug: Restasis (cyclosporine 0.05%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Measured: up to 12 weeks
Secondary outcomes (5)
Ocular Surface Disease Index(OSID)
Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.
Measured: 0 day, 4 weeks and 12 weeks
Tear Breakup Time(TBUT)
Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Measured: 0 day, 4 weeks and 12 weeks
Schirmer score
Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Measured: 0 day, 4 weeks and 12 weeks
Drug compliance
Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Measured: 0 day, 4 weeks and 12 weeks
DEWS(Dry Eye WorkShop) level
Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Measured: 0 day, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- DH Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BTO Pharm. Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hyo-Myung KIM, MD, PhD, Principal investigator, Korea University Anam HospitalJong Suk SONG, MD, PhD, Principal investigator, Korea University Guro HospitalHyung Keun LEE, MD, PhD, Principal investigator, Yonsei University Gangnam Severance HospitalJong-Soo LEE, MD, PhD, Principal investigator, Busan National University HospitalMee Kum KIM, MD, PhD, Principal investigator, Seoul National University HospitalMyoung-Joon KIM, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804361
- Sponsor's protocol ID
- UMT-2012-DH-HS-01
- Other IDs
- 1360-8040-3073-4190
- Status last verified
- Jul 2015
- First submitted
- 27 Feb 2013
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial
- ClinicalTrials.gov ID
- NCT01804361
- Acronym / sponsor ID
- UMT-2012-DH-HS-01
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- DH Bio Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- BTO Pharm. Co., Ltd.
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 2013 (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 determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.
Detailed description
This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.
Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haporine-S | Experimental | Drug: Haporine-SModerate to severe dry patients administered with with Haporine-S |
| Restasis, Cyclosporine 0.05% | Active comparator | Drug: Restasis (cyclosporine 0.05%)Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age 20 or over
- Patients with moderate to severe dry eye(DEWS Level II or over)
- Be informed of the nature of the study and will give written informed consent
Key exclusion criteria (10 listed)
- Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
- Being treated with systemic steroid or immunosuppressive
- History of eyeball surgical operation within 6 months
- Wearing contact lenses during participation of the study
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Haporine-S1 or 2 drops twice a day at 12 hour interval for 12 weeks | Drug | Haporine-S |
| Restasis (cyclosporine 0.05%)1 or 2 drops twice a day at 12 hour interval for 12 weeks | Drug | Restasis, Cyclosporine 0.05% |
Primary outcome
Corneal staining
Time frame: up to 12 weeks
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
5 secondary outcomes
Ocular Surface Disease Index(OSID)
Time frame: 0 day, 4 weeks and 12 weeks
Tear Breakup Time(TBUT)
Time frame: 0 day, 4 weeks and 12 weeks
Schirmer score
Time frame: 0 day, 4 weeks and 12 weeks
Drug compliance
Time frame: 0 day, 4 weeks and 12 weeks
DEWS(Dry Eye WorkShop) level
Time frame: 0 day, 4 weeks and 12 weeks
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 22 Jul 2015.
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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.
Hyo-Myung KIM, MD, PhD principal investigator
Korea University Anam Hospital
Jong Suk SONG, MD, PhD principal investigator
Korea University Guro Hospital
Hyung Keun LEE, MD, PhD principal investigator
Yonsei University Gangnam Severance Hospital
6 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 Haporine-S and Restasis (cyclosporine 0.05%) in people with Dry Eye Syndromes, run by DH Bio Co., Ltd. at 6 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 10 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Corneal staining (time frame: up to 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 22 Jul 2015.