Placebo-Controlled, Parallel-Group Study of SJP-0132 in Participants with Dry Eye Disease

SJP-0132 Phase 2 - A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study in Participants with Dry Eye Disease -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200243

Enrollment

332

Registered

2020-12-23

Start date

2020-12-25

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 Desease

Interventions

Administer SJP-0132 or placebo to participants with dry eye disease

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Have a continuous subjective symptoms of Dry Eye Disease - Tear film break-up time of <= 5 seconds - Have a fluorescein staining in the cornea - 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 - Have clinically active ophthalmic disease other than Dry Eye Disease - Have a known hypersensitivity or history of serious adverse reaction to any of the study drug ingredients - Have a history of, or scheduled corneal transplantation during the study - Have a history of, or scheduled permanent punctal occlusion during the study - Have used or anticipates use of a punctal plug during the study - Cannot discontinue any ophthalmic, nasal, or complementary medicines during the study - Have a history of, or scheduled eye surgery during the study - Pregnant, potentially pregnant, or lactating

Design outcomes

Primary

Measure	Time frame
Change from baseline in corneal fluorescein staining score	—

Contacts

Public ContactClinical development division

Senju Pharmaceutical Co., Ltd.

senju-clinicaltrials@senju.co.jp+81-78-777-1018

Outcome results

None listed

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