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NCT03597139 · ClinicalTrials.gov registry record · Phase 2

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

A Phase 2 study, sponsored by Aurinia Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target

NCT03597139: Completed Phase 2 study, sponsored by Aurinia Pharmaceuticals.

NCT03597139 is a Phase 2 study that has completed, run by Aurinia Pharmaceuticals. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03597139, a Phase 2 study, has completed, sponsored by Aurinia Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study Summary

Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

Primary Outcome

Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".

Interventions

  • DRUG Voclosporin Ophthalmic Solution
  • DRUG Restasis®

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2018-08-13
Est. Completion 2018-12-13
Phase Phase 2
Aurinia Pharmaceuticals

13 total trials

What the finished NCT03597139 record still lists

NCT03597139 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

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

NCT03597139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03597139 about?

NCT03597139 is a clinical study titled "Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease". Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

What is the current status of trial NCT03597139?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-08-13. Estimated completion is 2018-12-13.

What interventions are being tested in trial NCT03597139?

The interventions under investigation include: Voclosporin Ophthalmic Solution (DRUG), Restasis® (DRUG).

Who is sponsoring clinical trial NCT03597139?

This trial is sponsored by Aurinia Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03597139's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03597139, the US trial registry maintained by the National Library of Medicine. NCT03597139 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.