Skip to content

A multicenter, Single-arm trial to evaluate the efficacy and safety of trifluridine therapy for patients with keratoconjunctivitis caused by mpox virus.

A multicenter, Single-arm trial to evaluate the efficacy and safety of trifluridine therapy for patients with keratoconjunctivitis caused by mpox virus.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240048
Enrollment
20
Registered
2024-04-25
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis caused by Mpox virus

Interventions

Starting 2 weeks: 1 drop in the affected eye every 2 hours while awake (maximum of 9 drops per eye per day). Subsequent 1 week: 1 drop in the affected eye every 4 hours while awake (minimum 5 drops pe

Sponsors

Morioka Shinichiro
Lead Sponsor
Ohmagari Norio
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of 1) to 2) must be met. 1) Who are 6 years of age or older at the time of obtaining consent. 2) Those who have been diagnosed with keratoconjunctivitis caused by the Mpox virus. However, the diagnosis of empoxvirus shall be made when the pathogen is detected in conjunctival swab fluid by the following methods. Direct observation of virus particles by electron microscopy Detection of pathogens by separation and identification Detection of pathogen antigens by fluorescent antibody method Detection of pathogen genes by PCR

Exclusion criteria

Exclusion criteria: 1) Patients who have had anaphylaxis or serious systemic reactions to trifluridine in the past 2) Persons deemed inappropriate for inclusion in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the sum of the scores obtained by evaluating the following items. Eyelid skin findings: erythema, swelling, skin rash Conjunctival findings: hyperemia of the bulbar conjunctiva, elevated lesions/ulcers, ocular grease Corneal findings: superficial keratitis, infiltrates/ulcers, corneal opacity Other findings: corneal perforation, endophthalmitis, ocular inflammation

Secondary

MeasureTime frame
Viral load of conjunctival swab 7, 14, 21, and 30 days after test inclusion

Contacts

Public ContactSho Saito

National Center for Global Health and Medicine

ssaito@hosp.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026