Dry Eye DiseasePhase 1NCT03216096
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
A Phase 1 study of Dry Eye Disease, run by Santen Pharmaceutical Co., Ltd. at 2 sites in Taiwan.
Trial summary
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- 8 Sep 2017to 1 Feb 2018
- Phase
- Phase 1
- 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
- At least 6-month dry eye history
Who cannot join
- Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
- Diagnosed with keratoconjunctival chemical burns or thermal burn
- Eye disease other than dry eye disease which needs treatment
- Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
- Those who need to wear contact lenses during the clinical study
- Those who are considered inappropriate for this study by the investigator or subinvestigators
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Keelung Chang Gung Memorial Hospital
Keelung
National Taiwan University Hospital
Taipei
About this study
Official title: A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.
- Conditions
- Dry Eye Disease
- Being tested
- Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
- 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.
Placebo ophthalmic solution and 3% DE-089 ophthalmic solutionDrug
Placebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period
| Study group | Role | What they receive |
|---|---|---|
| 3% DE-089 ophthalmic solution | Experimental | Not described Receives: Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining score
Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start8 Sep 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216096
- Sponsor's protocol ID
- 00891601
- Status last verified
- Aug 2018
- First submitted
- 10 Jul 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT03216096
- Acronym / sponsor ID
- 00891601
- Conditions
- Dry Eye Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 13 Jul 2017 (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.
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3% DE-089 ophthalmic solution | Experimental | Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 6-month dry eye history
Key exclusion criteria (6 listed)
- Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
- Diagnosed with keratoconjunctival chemical burns or thermal burn
- Eye disease other than dry eye disease which needs treatment
- Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
- Those who need to wear contact lenses during the clinical study
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 |
|---|---|---|
| Placebo ophthalmic solution and 3% DE-089 ophthalmic solutionPlacebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period | Drug | 3% DE-089 ophthalmic solution |
Primary outcome
Corneal fluorescein staining score
Time frame: Week 4
Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
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 31 Aug 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Dry Eye Disease, run by Santen Pharmaceutical Co., Ltd. at 2 sites in Taiwan.
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 1 inclusion and 6 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 fluorescein staining score (time frame: Week 4). 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 31 Aug 2018.