Epithelial herpetic keratitis Epithelial herpetic keratitis
Conditions
Interventions
Amenamevir(Amenalief) 200mg (2 tablets) is orally administered once daily after breakfast for 14 days.
Sponsors
Inoue Yoshitsugu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women more than 20 years old in the timing of participation agreement 2) Patients with herpetic epithelial keratitis resistant to 2 weeks treatment by acyclovir ointment
Exclusion criteria
Exclusion criteria: 1) Patients with allergy to amenamevir infection of bacteria or fungi 2) Pregnant or possibly pregnant women 3) Women during breast-feeding 4) Patients who were administered other experimental or investigational drugs within 3 months before the start of amenamevir 5) Patients with administration of drugs to become substrates of cytochrome P450 6) Patients with administration of drugs to inhibit cytochrome P4503A 7) Patients with administration of drugs to induce cytochrome P4503A 8) Patients with administration of drugs to become substrates of cytochrome P4502B6 9) Patients with administration of ciclosporin 10) Patients with administration of antiviral drugs 11) Patients with past history of heart diseases 12) Patients with past history of hematogenous diseases 13) Patients with severe lever diseases 14) Patients with secondary corneal or conjunctival infection of bacteria or fungi 15) Others, Patients who were decided inappropriate to this study by the primary responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disappearance of herpetic epithelial lesion in 14 days after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation: the reduction of herpetic epithelial lesion size and HSV-DNA copy number Safety evaluation: adverse event, laboratory values (hematological test, blood biochemistry, urinalysis), vital signs, 12-lead ECG | — |
Contacts
Public ContactYoshitsugu Inoue
Tottori University Hospital
Outcome results
None listed