KeratoconjunctivitisPhase 3NCT00567762
Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
A Phase 3 study testing FK506 in people with Keratoconjunctivitis and Conjunctivitis, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Keratoconjunctivitis, Conjunctivitis
- What is being tested?
- FK506
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 8 sitesJapan
- Study dates
- Feb 2004to Sep 2004
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
- Patients with type I reactions defined by skin testing, antibody measurement, etc.
- Age over 6 years old
Who cannot join
- Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
- Subjects needed to wear contact lenses during treatment period on a testing eye
- Subjects complicating an eye infection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Ehime
Study site
Hokkaido
Study site
Kagoshima
Study site
Kochi
Study site
Miyazaki
Study site
Osaka
Study site
Tochigi
Study site
Tokyo
About this study
Official title: A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
Read the detailed description
0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.
- Conditions
- Keratoconjunctivitis, Conjunctivitis
- Being tested
- FK506, placebo
- Keywords
- Keratoconjunctivitis, vernal keratoconjunctivitis, FK506, Tacrolimus
- Medical subject headings
- Keratoconjunctivitis, Conjunctivitis, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK506Drug
Also called tacrolimius
Opthalmic suspension
placeboDrug
placebo eye drops
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FK506 ophthalmic suspension Receives: Drug: FK506 |
| 2 | Placebo comparator | Base of eye drops Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
Measured: 4 weeks
Secondary outcomes (3)
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
Measured: Week 1, 2 and 4
Subjective symptom score (Visual Analog Scale)
Measured: 4 weeks
The improvement rate of subjective symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startFeb 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconjunctivitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567762
- Sponsor's protocol ID
- FJ-506D-AC09
- Status last verified
- Aug 2014
- First submitted
- 3 Dec 2007
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT00567762
- Acronym / sponsor ID
- FJ-506D-AC09
- Conditions
- Keratoconjunctivitis, Conjunctivitis
- Keywords
- Keratoconjunctivitis, vernal keratoconjunctivitis, FK506, Tacrolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Sep 2004 (actual)
- First posted
- 5 Dec 2007 (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 investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
Detailed description
0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FK506FK506 ophthalmic suspension |
| 2 | Placebo comparator | Drug: placeboBase of eye drops |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
- Patients with type I reactions defined by skin testing, antibody measurement, etc.
- Age over 6 years old
Key exclusion criteria (3 listed)
- Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
- Subjects needed to wear contact lenses during treatment period on a testing eye
- Subjects complicating an eye infection
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 |
|---|---|---|
| FK506Also: tacrolimiusOpthalmic suspension | Drug | 1 |
| placeboplacebo eye drops | Drug | 2 |
Primary outcome
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
Time frame: 4 weeks
3 secondary outcomes
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
Time frame: Week 1, 2 and 4
Subjective symptom score (Visual Analog Scale)
Time frame: 4 weeks
The improvement rate of subjective symptoms
Time frame: 4 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 1 Sep 2014.
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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.
Central Contact study chair
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FK506 in people with Keratoconjunctivitis and Conjunctivitis, run by Astellas Pharma Inc at 8 sites 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 3 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 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation (time frame: 4 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 1 Sep 2014.