NIPH Clinical Trials Search

UMIN ID: UMIN000001262

Registered date:01/09/2008

Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedVernal keratoconjunctivitis
Date of first enrollment2008/05/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)TALYMUS Ophthalmic Suspension 0.1%(tacrolimus) Twice daily for 12 weeks


Primary OutcomeBlood levels of tacrolimus Mean change in the total score of objective clinical signs
Secondary OutcomeChange of 10 objective clinical signs Change of 6 subjective symptoms

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaSubjects are ineligible to participate in this study, if they: 1. have a known hypersensitivity to tacrolimus hydrate or to any component of this drug 2. Are suffering from infectious eye disease 3. Are pregnant or may possibly be pregnant 4. Have used ocular tacrolimus hydrate(including clinical trials) 5. Need to take tacrolymus capsules, granules and/or injection(Prograf) 6. Need to wear contact lenses during treatment period 7. Have participated in any other clinical trials within 3 months prior to enrollment, or will be enrolled in any other clinical trials during the study period 8. Were judged an inadequate subject to enrollment by a medical doctor

Related Information


public contact
Address Japan
Affiliation Senju Pharmaceutical Co., Ltd Post Marketing Surveillance Department
scientific contact
Name Yuichi Ohashi
Address Shitsukawa, Touon-city, Ehime,Japan Japan
Affiliation Ehime University, School of Medicine Department of Ophthalmology