ROH-201 ophthalmic solution phase IIb clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220368

Enrollment

300

Registered

2022-10-07

Start date

2022-10-25

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

Dry eye disease

Interventions

Administration of ROH-201 ophthalmic or placebo to patients with dry eye

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Tear film break-up time of <= 5 seconds - Have a subjective symptoms of Dry Eye Disease - 20 years and older at the time of Informed Consent

Exclusion criteria

Exclusion criteria: - Contact lens wearers who cannot discontinue the wear over the trial period

Design outcomes

Primary

Measure	Time frame
Amount of change from baseline in staining score	—

Contacts

Public ContactTomomi Mantani

ROHTO Pharmaceutical Co., Ltd.

rohtocl@rohto.co.jp+81-6-6758-6925

Outcome results

None listed

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