CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 508 enrolled
Drug / intervention
0.05% Voclosporin Ophthalmic Solution (VOS) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04147650
NCT04147650Phase 3Completed
CompareCT.gov

A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)

Aurinia Pharmaceuticals Inc.·interventional·Posted Nov 1, 2019·Updated Dec 10, 2021

In Brief

A Phase 3 clinical trial evaluating 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS, and 2 other interventions for Dry Eye Syndrome and Keratoconjunctivitis Sicca. Completed, enrolled 508 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome, Keratoconjunctivitis Sicca
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 1, 2019
Enrollment StartOct 14, 2019
Primary CompletionSep 17, 2020
Study CompletionOct 8, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.7 years ago

Interventions

0.05% Voclosporin Ophthalmic Solution (VOS)drug

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

0.10% VOSdrug

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

0.20% VOSdrug

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

Vehicle Ophthalmic Solutiondrug

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