Dry Eye SyndromesPhase 3NCT04384991
HU007 Eye Drops in Patients With Dry Eye Syndrome
A Phase 3 study testing HU007 and Restasis eye drop in people with Dry Eye Syndromes, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, 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 Syndromes
- What is being tested?
- HU007 and Restasis eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 May 2019to 5 Dec 2019
- 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
- Male and Female who over 19 years old
- Those who meet below criteria at least one of two eyes
- Those who have over than score 2 in corneal staining test-Oxford grading
- Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
- TBUT(Tear film break-up time) test result should be under 10sec.
- Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
- Those who could understand this study and agree to informed consent voluntarily
Who cannot join
- Those who have clinically significant eye disease not related to dry eye symdrome
- Those who are in anti-inflammatory medication for dry eye syndrome
- Medication of systemic steroid or immunosuppressant
- Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- Those who have medical history with intraocular surgery 90 days before screening visit
- Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
Show all 19Show fewer
- Those who have any autoimmune diseases
- Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
- Those who have any medical history of corneal transplantation or neurotrophic keratitis
- Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
- Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
- Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
- Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
- Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
- Those who have diagnosed a psychical disorder which could affect this study
- Women who is pregnant or breastfeeding or those who have a plan to be pregnant
- Those who have medical history on abusing medications or alchol
- Those who have received other investigational drugs/devices 30 days before screening visit
- Those who are inappropriate for participating in this study according to investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With dry eye syndrome
- Conditions
- Dry Eye Syndromes
- Being tested
- HU007, Restasis eye drop
- 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% with Trehalose 3%
Restasis eye dropDrug
Cyclosporine 0.05%
| Study group | Role | What they receive |
|---|---|---|
| HU007 Eye drop | Experimental | Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down.
Medication is recommended at 9AM(±1H) and 9PM(±1H) Receives: Drug: HU007 |
| Restasis Eye drop 0.05% (Cyclosporine) | Active comparator | Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down.
Medication is recommended at 9AM(±1H) and 9PM(±1H) Receives: Drug: Restasis eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 12
Measured: Week 12
Secondary outcomes (6)
Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 4, 8
Measured: Week 4, 8
Change from baseline in conjunctival staining score-Oxford grading
Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12
Measured: Week 4, 8, 12
Change from baseline in strip meniscometry
Change from baseline in strip meniscometry at Week 4, 8, 12
Measured: Week 4, 8, 12
Change from baseline in Tear film break-up time
Change from baseline in Tear film break-up time at Week 4, 8, 12
Measured: at Week 4, 8, 12
Change from Baseline of Standard patient evaluation of eye dryness questionnaire
Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12
Measured: at Week 4, 8, 12
Time to achieve 100% clearance on the corneal staining score
Time to achieve 100% clearance on the corneal staining score
Measured: upto week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start3 May 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
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
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384991
- Sponsor's protocol ID
- HU-007_P3-1
- Status last verified
- May 2020
- First submitted
- 16 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD would be substituted for screening or random No.
Study at a glance
From the registry record, last updated by the sponsor on 12 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, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT04384991
- Acronym / sponsor ID
- HU-007_P3-1
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 12 May 2020 (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.
This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, 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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HU007 Eye drop | Experimental | Drug: HU007Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H) |
| Restasis Eye drop 0.05% (Cyclosporine) | Active comparator | Drug: Restasis eye dropAdminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and Female who over 19 years old
- Those who meet below criteria at least one of two eyes
- Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
- Those who could understand this study and agree to informed consent voluntarily
Key exclusion criteria (19 listed)
- Those who have clinically significant eye disease not related to dry eye symdrome
- Those who are in anti-inflammatory medication for dry eye syndrome
- Medication of systemic steroid or immunosuppressant
- Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- Those who have medical history with intraocular surgery 90 days before screening visit
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% with Trehalose 3% | Drug | HU007 Eye drop |
| Restasis eye dropCyclosporine 0.05% | Drug | Restasis Eye drop 0.05% (Cyclosporine) |
Primary outcome
Change from baseline in corneal staining score-Oxford grading
Time frame: Week 12
Change from baseline in corneal staining score-Oxford grading at Week 12
6 secondary outcomes
Change from baseline in corneal staining score-Oxford grading
Time frame: Week 4, 8
Change from baseline in conjunctival staining score-Oxford grading
Time frame: Week 4, 8, 12
Change from baseline in strip meniscometry
Time frame: Week 4, 8, 12
Change from baseline in Tear film break-up time
Time frame: at Week 4, 8, 12
Change from Baseline of Standard patient evaluation of eye dryness questionnaire
Time frame: at Week 4, 8, 12
Time to achieve 100% clearance on the corneal staining score
Time frame: upto week 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 12 May 2020.
- Individual participant dataSharing planned: No. IPD would be substituted for screening or random 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Restasis eye drop in people with Dry Eye Syndromes, 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 7 inclusion and 19 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 12 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 score-Oxford grading (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 12 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.