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NCT03527212 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease

A Phase 3 study, sponsored by Senju Pharmaceutical Co..

Completed
Registry status
Phase 3
Development phase
329
Enrollment target

NCT03527212: Completed Phase 3 study, sponsored by Senju Pharmaceutical Co..

NCT03527212 is a Phase 3 study that has completed, run by Senju Pharmaceutical Co.. The registered enrollment target is 329 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03527212, a Phase 3 study, has completed, sponsored by Senju Pharmaceutical Co..

COMPLETED
Registry status
Phase 3
Development phase
329 participants
Enrollment target

Study Summary

A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

Primary Outcome

Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.

Interventions

  • DRUG Placebo
  • DRUG SJP-0035 0.001%

Trial Details

FieldValue
Enrollment Target 329 participants
Start Date 2018-08-20
Est. Completion 2019-03-15
Phase Phase 3
Senju Pharmaceutical Co.

5 total trials

What the finished NCT03527212 record still lists

NCT03527212 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03527212 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03527212 about?

NCT03527212 is a clinical study titled "A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease". A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

What is the current status of trial NCT03527212?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 329 participants. The study started on 2018-08-20. Estimated completion is 2019-03-15.

What interventions are being tested in trial NCT03527212?

The interventions under investigation include: Placebo (DRUG), SJP-0035 0.001% (DRUG).

Who is sponsoring clinical trial NCT03527212?

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

How this trial's enrollment target compares

Where NCT03527212's enrollment target sits among peer trials

329 1074th of 2000 higher than 927 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT03527212, the US trial registry maintained by the National Library of Medicine. NCT03527212 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.