Vernal keratoconjunctivitis
Conditions
Interventions
TALYMUS Ophthalmic Suspension 0.1%(tacrolimus) Twice daily for 12 weeks
Sponsors
Senju Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Vernal keratoconjunctivitis patients who have giant papillae despite the prior treatment with anti-allergic agents
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of tacrolimus Mean change in the total score of objective clinical signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of 10 objective clinical signs Change of 6 subjective symptoms | — |
Countries
Japan
Outcome results
None listed