Dry Eye SyndromePhase 2NCT02917512
Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
A Phase 2 study testing HU00701, HU007 and Restasis in people with Dry Eye Syndrome, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- HU00701, HU007 and Restasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2016
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- 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
- Volunteer who has negative result of pregnancy test or use effective contraception
Who cannot join
- Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- The patients with systemic or ocular disorders affected the test result
- Being treated with systemic steroid
- Wearing contact lenses within 3 days of screening visit
- Pregnancy or Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome
- Conditions
- Dry Eye Syndrome
- Being tested
- HU00701, HU007, Restasis, 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.
HU00701Drug
Cyclosporine 0.01% + 3% trehalose
HU007Drug
Cyclosporine 0.02% + 3% trehalose
RestasisDrug
Cyclosporine 0.05%
PlaceboDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| HU00701 | Experimental | HU00701(Cyclosporine 0.01% + 3% trehalose)
1 drop b.i.d at 12 hour interval for 12 weeks Receives: Drug: HU00701 |
| HU007 | Experimental | HU007(Cyclosporine 0.02% + 3% trehalose)
1 drop b.i.d at 12 hour interval for 12 weeks Receives: Drug: HU007 |
| Restasis | Active comparator | Restasis(Cyclosporine 0.05%)
1 drop b.i.d at 12 hour interval for 12 weeks Receives: Drug: Restasis |
| Placebo(without main component) | Placebo comparator | Placebo
1 drop b.i.d at 12 hour interval for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Baseline of Corneal staining score - Oxford grading
Measured: Week 12
Secondary outcomes (4)
change from Baseline of Corneal staining score - Oxford grading
Measured: Week 4, 8
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-il Baek, Study director, Huons Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917512
- Sponsor's protocol ID
- HU-007_P2
- Status last verified
- Apr 2018
- First submitted
- 26 Sep 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.
PubMed 33449860
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02917512
- Acronym / sponsor ID
- HU-007_P2
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 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.
A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HU00701 | Experimental | Drug: HU00701HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks |
| HU007 | Experimental | Drug: HU007HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks |
| Restasis | Active comparator | Drug: RestasisRestasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks |
| Placebo(without main component) | Placebo comparator | Drug: PlaceboPlacebo 1 drop b.i.d at 12 hour interval for 12 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
- Volunteer who has negative result of pregnancy test or use effective contraception
Key exclusion criteria (5 listed)
- Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- The patients with systemic or ocular disorders affected the test result
- Being treated with systemic steroid
- Wearing contact lenses within 3 days 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 |
|---|---|---|
| HU00701Cyclosporine 0.01% + 3% trehalose | Drug | HU00701 |
| HU007Cyclosporine 0.02% + 3% trehalose | Drug | HU007 |
| RestasisCyclosporine 0.05% | Drug | Restasis |
| PlaceboVehicle | Drug | Placebo(without main component) |
Primary outcome
change from Baseline of Corneal staining score - Oxford grading
Time frame: Week 12
4 secondary outcomes
change from Baseline of Corneal staining score - Oxford grading
Time frame: Week 4, 8
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
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 Apr 2018.
- Derived from this study: PubMed 33449860Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.
- 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.
Seung-il Baek study director
Huons Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HU00701, HU007 and Restasis 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 4 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 12 Apr 2018. 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. 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 from Baseline of 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?
On the ClinicalTrials.gov record for NCT02917512, which also lists 1 linked publication.
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 Apr 2018.