Dry Eye SyndromePhase 3NCT03461575
Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
A Phase 3 study testing HU007, Restasis and Moisview in people with Dry Eye Syndrome, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops 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?
- HU007, Restasis and Moisview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2018to 12 Jul 2018
- 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
- age over 19
- Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
- Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception
Who cannot join
- The patients with systemic or ocular disorders affected the test result
- Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- Being treated with systemic steroid
- Wearing contact lenses within 72 hr of screening visit
- Pregnancy or Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
- Conditions
- Dry Eye Syndrome
- Being tested
- HU007, Restasis, Moisview
- 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.
HU007Drug
cyclosporine 0.02%, trehalose 3%
RestasisDrug
cyclosporine 0.05%
MoisviewDrug
trehalose 3%
| Study group | Role | What they receive |
|---|---|---|
| HU007 | Experimental | Cyclosporine 0.02%, trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks Receives: Drug: HU007 |
| Restasis | Active comparator | Cyclosporine 0.05%
1 drop b.i.d at 12hr interval for 12 weeks Receives: Drug: Restasis |
| Moisview | Active comparator | trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks Receives: Drug: Moisview |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Baseline in Corneal staining(Oxford grading) score
Measured: Week 12
Secondary outcomes (7)
change from Baseline in Corneal staining(Oxford grading) score
Measured: Week 4,8
change from Baseline of Conjunctival staining(Oxford grading) score
Measured: Week 4,8,12
change from Baseline of Strip meniscometry assessment
Measured: Week 4,8,12
change from Baseline of Tear film break-up time
Measured: Week 4,8,12
change from Baseline of Standard patient evaluation of eye dryness questionnaire
Measured: Week 4,8,12
arrival time of 100% clearence in Corneal staining test
Measured: Week 0-12
The number of total rescue drug usage
Measured: Week 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start22 Jan 2018
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Namsick Kim, Study director, Huons Co., Ltd.Choun-Ki Joo, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461575
- Sponsor's protocol ID
- HU-007_P3
- Status last verified
- Apr 2018
- First submitted
- 5 Mar 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03461575
- Acronym / sponsor ID
- HU-007_P3
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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.
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HU007 | Experimental | Drug: HU007Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
| Restasis | Active comparator | Drug: RestasisCyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks |
| Moisview | Active comparator | Drug: Moisviewtrehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 19
- Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
- Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception
Key exclusion criteria (5 listed)
- The patients with systemic or ocular disorders affected the test result
- Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- Being treated with systemic steroid
- Wearing contact lenses within 72 hr of screening visit
- 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 |
|---|---|---|
| HU007cyclosporine 0.02%, trehalose 3% | Drug | HU007 |
| Restasiscyclosporine 0.05% | Drug | Restasis |
| Moisviewtrehalose 3% | Drug | Moisview |
Primary outcome
change from Baseline in Corneal staining(Oxford grading) score
Time frame: Week 12
7 secondary outcomes
change from Baseline in Corneal staining(Oxford grading) score
Time frame: Week 4,8
change from Baseline of Conjunctival staining(Oxford grading) score
Time frame: Week 4,8,12
change from Baseline of Strip meniscometry assessment
Time frame: Week 4,8,12
change from Baseline of Tear film break-up time
Time frame: Week 4,8,12
change from Baseline of Standard patient evaluation of eye dryness questionnaire
Time frame: Week 4,8,12
arrival time of 100% clearence in Corneal staining test
Time frame: Week 0-12
The number of total rescue drug usage
Time frame: Week 0-12
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 8 May 2020.
- 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.
Namsick Kim study director
Huons Co., Ltd.
Choun-Ki Joo principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HU007, Restasis and Moisview in people with Dry Eye Syndrome, run by Huons Co., Ltd. at 1 site 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 5 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change from Baseline in Corneal staining(Oxford grading) score (time frame: Week 12). 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 8 May 2020.