deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03597139

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

An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Sponsor: Aurinia Pharmaceuticals Inc.

Conditions Dry Eye
Updated 9 times since 2018 Last updated: Jul 5, 2021 Started: Aug 13, 2018 Primary completion: Nov 9, 2018 Completion: Dec 13, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Dry Eye, this trial is completed. The trial is conducted by Aurinia Pharmaceuticals Inc. and has accumulated 9 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US

Status Flow

~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshotNot Yet Recruiting~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshotRecruiting~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshotRecruiting~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshotActive Not Recruiting~Feb 2019 – ~Jan 2021 · 23 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE2

  5. Feb 2019 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Dec 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  3. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  4. Aug 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aurinia Pharmaceuticals Inc.
Data source: Aurinia Pharmaceuticals Inc.

For direct contact, visit the study record on ClinicalTrials.gov .