ROH-101 phase 3 study - uncontrolled open-label study in patients with cytomegalovirus corneal endotheliitis -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051210064

Enrollment

Registered

2021-08-13

Start date

2021-08-02

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

cytomegalovirus corneal endotheliitis

Interventions

One drop of ROH-101(0.15%) 5 times a day for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who diagnose as CMV endotheliitis based on the clinical manifestations of (1) or (2). (1) Patients who show coin-shaped lesions or linear keratic precipitates (KPs). (2) Patients who show other KPs combined with more than 2 of following signs; anterior uveitis, ocular hypertension and corneal endothelial cell loss. 2) Patients who are CMV DNA positive by examination of qualitative PCR of aqueous humor.

Exclusion criteria

Exclusion criteria: 1) Patients who are HSV or VZV positive by examination of qualitative PCR of aqueous humor.

Design outcomes

Primary

Measure	Time frame
The percentage of patients who achieved <1000 copies /ml(detected limit) in aqueous humor Real-time PCR	—

Contacts

Public ContactTomomi Mantani

Rohto Pharmaceutical Co.,Ltd.

rohtocl@rohto.co.jp+81-774-71-8802

Outcome results

None listed

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