Dry Eye With Sjögren's SyndromePhase 3NCT02503189
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
A Phase 3 study testing KCT-0809 ophthalmic solution in people with Dry Eye With Sjögren's Syndrome, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye With Sjögren's Syndrome
- What is being tested?
- KCT-0809 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Start not givento Jan 2017
- 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 20 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Who cannot join
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome
- Conditions
- Dry Eye With Sjögren's Syndrome
- Being tested
- KCT-0809 ophthalmic solution, Placebo
- Keywords
- Dry eye syndromes, Corneal diseases, Conjunctival diseases
- Medical subject headings
- Dry Eye Syndromes, Corneal Diseases, Conjunctival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KCT-0809 ophthalmic solutionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KCT-0809 | Experimental | Not described Receives: Drug: KCT-0809 ophthalmic solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the corneal staining
Measured: 12 weeks
Secondary outcomes (1)
Score of the conjunctival staining
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 posted20 Jul 2015 (estimated)
- Primary completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye With Sjögren's 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
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503189
- Sponsor's protocol ID
- KCT1301
- Status last verified
- May 2017
- First submitted
- 17 Jul 2015
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT02503189
- Acronym / sponsor ID
- KCT1301
- Conditions
- Dry Eye With Sjögren's Syndrome
- Keywords
- Dry eye syndromes, Corneal diseases, Conjunctival diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Jan 2017 (actual)
- First posted
- 20 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 investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KCT-0809 | Experimental | Drug: KCT-0809 ophthalmic solution |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Key exclusion criteria (2 listed)
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
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 |
|---|---|---|
| KCT-0809 ophthalmic solution | Drug | KCT-0809 |
| Placebo | Drug | Placebo |
Primary outcome
Score of the corneal staining
Time frame: 12 weeks
1 secondary outcome
Score of the conjunctival staining
Time frame: 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 17 May 2017.
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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 KCT-0809 ophthalmic solution in people with Dry Eye With Sjögren's Syndrome, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
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 2 inclusion and 2 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 17 May 2017. 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 Japan. 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 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?
Score of the corneal staining (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 17 May 2017.