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Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease

NCT06717152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2025-11-26

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of SJP-0132 in Chinese Patients with Dry Eye.

Patients will be randomly assigned to receive either SJP-0132 or placebo.

Conditions

  • Dry Eye

Interventions

DRUG

SJP-0132

Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group.

DRUG

Placebo

Aqueous eye drop, one drop each time and four times each day, 2 weeks in run-in period in both groups and 8 weeks in treatment period in placebo group.

Sponsors & Collaborators

  • Senju Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kazunori Omatsu · Senju Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2025-07-28
Completion
2025-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717152 on ClinicalTrials.gov