Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Phase 4
- Conditions
- Vernal keratoconjunctivitis
- Registration Number
- JPRN-UMIN000001262
- Lead Sponsor
- Senju Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Subjects 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood levels of tacrolimus Mean change in the total score of objective clinical signs
- Secondary Outcome Measures
Name Time Method Change of 10 objective clinical signs Change of 6 subjective symptoms