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| Descriptive Information Fields | |||||
| Brief Title † | Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis | ||||
| Official Title † | A Randomized, Placebo-Controlled, Double-Masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis | ||||
| Brief Summary | To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| 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 ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Keratoconjunctivitis Conjunctivitis |
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| Intervention † | Drug: FK506 Drug: placebo |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 56 | ||||
| Start Date † | February 2004 | ||||
| Completion Date | September 2004 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00567762 | ||||
| Organization ID | FJ-506D-AC09 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Astellas Pharma Inc | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Astellas Pharma Inc | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | December 3, 2007 | ||||
| Last Updated Date | December 3, 2007 | ||||