Dry Eye SyndromePhase 3NCT02492412
Efficacy and Safety of HE10 for Dry Eye Syndrome
A Phase 3 study testing HE 10 and Restasis in people with Dry Eye Syndrome, run by Huons Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- HE 10 and Restasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Sep 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal staining score of ≥2(Oxford grade)
- Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
- Tear break-up time is 10 seconds or less
- Screening both eyes, the corrected visual acuity is 0.2 or more
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
- History of eyeball surgical operation within 3 months of screening visit
- Wearing contact lenses within 2 weeks of screening visit
- Be a use or used punctual plug within 1 month of screening vist
Show all 10Show fewer
- Use of cyclosporine eye drop within 3 weeks
- Pregnancy or Breastfeeding
- Intraocular pressure > 25 mmHg
- Abnormal eyelid function : Disorders of the eyelids or eyelashes
About this study
Official title: Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.
Read the detailed description
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.
- Conditions
- Dry Eye Syndrome
- Being tested
- HE 10, Restasis
- 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.
HE 10Drug
RestasisDrug
Also called 0.05% cyclosporine
| Study group | Role | What they receive |
|---|---|---|
| HE10 | Experimental | Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks Receives: Drug: HE 10 |
| Restasis | Active comparator | Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks Receives: Drug: Restasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining Test to assess eye dryness
Change from baseline in eye dryness at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionSep 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 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
- NCT02492412
- Sponsor's protocol ID
- Huons
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02492412
- Acronym / sponsor ID
- Huons
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Jul 2015 (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 evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.
Detailed description
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HE10 | Experimental | Drug: HE 10Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks |
| Restasis | Active comparator | Drug: RestasisDrug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Corneal staining score of ≥2(Oxford grade)
- Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
- Tear break-up time is 10 seconds or less
- Screening both eyes, the corrected visual acuity is 0.2 or more
Key exclusion criteria (10 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
- History of eyeball surgical operation within 3 months of screening visit
- Wearing contact lenses within 2 weeks of 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 |
|---|---|---|
| HE 10 | Drug | HE10 |
| RestasisAlso: 0.05% cyclosporine | Drug | Restasis |
Primary outcome
Corneal staining Test to assess eye dryness
Time frame: 12 weeks
Change from baseline in eye dryness at 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 8 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HE 10 and Restasis in people with Dry Eye Syndrome, run by Huons Co., Ltd..
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 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Test to assess eye dryness (time frame: 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 8 Jul 2015.