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NCT04139122 · ClinicalTrials.gov registry record · Phase 1

Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

A Phase 1 study of Dry Eye Disease and Dry Eye Syndrome, sponsored by Senju Pharmaceutical Co..

Completed
Registry status
Phase 1
Development phase
89
Enrollment target
1
Study location

NCT04139122: Completed Phase 1 study of Dry Eye Disease and Dry Eye Syndrome, sponsored by Senju Pharmaceutical Co..

NCT04139122 is a Phase 1 study of Dry Eye Disease and Dry Eye Syndrome that has completed, run by Senju Pharmaceutical Co.. The registered enrollment target is 89 participants, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04139122, a Phase 1 study of Dry Eye Disease and Dry Eye Syndrome, has completed, sponsored by Senju Pharmaceutical Co..

COMPLETED
Registry status
Phase 1
Development phase
89 participants
Enrollment target
1
Study location

Study Summary

This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease

Primary Outcome

Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.

Interventions

  • DRUG Placebo
  • DRUG SJP-0132

Study Locations (1)

California

  • Senju Investigational Site - Cypress

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2019-10-05
Est. Completion 2020-03-03
Phase Phase 1
Senju Pharmaceutical Co.

5 total trials

What the finished NCT04139122 record still lists

NCT04139122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (65% lower).

The record links to 2 conditions, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04139122 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04139122 about?

NCT04139122 is a clinical study titled "Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease". This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease

What is the current status of trial NCT04139122?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2019-10-05. Estimated completion is 2020-03-03.

What conditions does trial NCT04139122 study?

This clinical trial studies the following conditions: Dry Eye Disease, Dry Eye Syndrome.

What interventions are being tested in trial NCT04139122?

The interventions under investigation include: Placebo (DRUG), SJP-0132 (DRUG).

Who is sponsoring clinical trial NCT04139122?

This trial is sponsored by Senju Pharmaceutical Co., which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04139122 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Dry Eye Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04139122's enrollment target sits among peer trials

89 24th of 33 higher than 10 of 33 other Dry Eye Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04139122, the US trial registry maintained by the National Library of Medicine. NCT04139122 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.