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) studied | Vernal keratoconjunctivitis |
| Date of first enrollment | 2008/05/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TALYMUS Ophthalmic Suspension 0.1%(tacrolimus) Twice daily for 12 weeks |
Outcome(s)
| Primary Outcome | Blood levels of tacrolimus Mean change in the total score of objective clinical signs |
|---|---|
| Secondary Outcome | Change of 10 objective clinical signs Change of 6 subjective symptoms |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Senju Pharmaceutical Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Senju Pharmaceutical Co., Ltd |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| t-suenobu@senju.co.jp | |
| Affiliation | Senju Pharmaceutical Co., Ltd Post Marketing Surveillance Department |
| scientific contact | |
| Name | Yuichi Ohashi |
| Address | Shitsukawa, Touon-city, Ehime,Japan Japan |
| Telephone | |
| Affiliation | Ehime University, School of Medicine Department of Ophthalmology |