Dry Eye SyndromesPhase 2NCT01427816
A Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
A Phase 2 study testing KCT-0809 in people with Dry Eye Syndromes, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- KCT-0809
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal and conjunctival damage
- Insufficiency of lacrimal secretion
- Ocular symptom
Who cannot join
- Severe ophthalmic disorder
- Punctual plugs or surgery for occlusion of the lacrimal puncta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.
- Conditions
- Dry Eye Syndromes
- Being tested
- KCT-0809, 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-0809Drug
KCT-0809Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KCT-0809 ophthalmic solution, low dose | Experimental | Not described Receives: Drug: KCT-0809 |
| KCT-0809 ophthalmic solution, high dose | Experimental | Not described Receives: Drug: KCT-0809 |
| 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.
Corneal staining score
Measured: 6 weeks
Secondary outcomes (1)
Conjunctival staining score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsumi Hontani, Study director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427816
- Sponsor's protocol ID
- KCT1202
- Status last verified
- Oct 2013
- First submitted
- 1 Sep 2011
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01427816
- Acronym / sponsor ID
- KCT1202
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye syndromes, Corneal diseases, Conjunctival diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 2 Sep 2011 (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.
To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KCT-0809 ophthalmic solution, low dose | Experimental | Drug: KCT-0809 |
| KCT-0809 ophthalmic solution, high dose | Experimental | Drug: KCT-0809 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Corneal and conjunctival damage
- Insufficiency of lacrimal secretion
- Ocular symptom
Key exclusion criteria (2 listed)
- Severe ophthalmic disorder
- Punctual 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 | Drug | KCT-0809 ophthalmic solution, low dose |
| KCT-0809 | Drug | KCT-0809 ophthalmic solution, high dose |
| Placebo | Drug | Placebo |
Primary outcome
Corneal staining score
Time frame: 6 weeks
1 secondary outcome
Conjunctival staining score
Time frame: 6 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 30 Oct 2013.
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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.
Katsumi Hontani study director
Clinical Development Department, Kissei pharmaceutical 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 KCT-0809 in people with Dry Eye Syndromes, 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 3 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 30 Oct 2013. 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 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?
Corneal staining score (time frame: 6 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 30 Oct 2013.