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Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

NCT04147650 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2021-12-10

Study results available
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Summary

A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.

Conditions

  • Dry Eye Syndrome
  • Keratoconjunctivitis Sicca

Interventions

DRUG

0.05% Voclosporin Ophthalmic Solution (VOS)

0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

DRUG

0.10% VOS

0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

DRUG

0.20% VOS

0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Palmen · Aurinia Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2020-09-17
Completion
2020-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04147650 on ClinicalTrials.gov