Trial · NCT04147650
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
NCT04147650, Phase 2, Phase 3, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2021-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome. Trials, record NCT04147650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04147650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
- NCT number
- NCT04147650
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 508 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- Interventions
- 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS, 0.20% VOS, Vehicle Ophthalmic Solution
- First posted
- 2019-11-01
- Last updated
- 2021-12-10
- Results first posted
- 2021-12-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 4 Weeks | Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale. |
| Secondary | Change From Baseline in Eye Dryness | Value at 4 Weeks minus value at baseline | Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 4 Weeks | Modified intent to treat (mITT) number of subjects achieving ≥10 mm increase improvement at week 4 | participants | NUMBER |
| SECONDARY | Change From Baseline in Eye Dryness | Value at 4 Weeks minus value at baseline | The analysis was performed using all mITT subjects with a baseline eye dryness VAS ≥60 mm. Subjects without a Week 4 eye dryness VAS score were not included in this analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 12 | participants | ||
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 0.10% VOS | 10 | participants | ||
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 0.20% VOS | 13 | participants | ||
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | Vehicle Ophthalmic Solution | 6 | participants | ||
| Change From Baseline in Eye Dryness | 0.05% Voclosporin Ophthalmic Solution (VOS) | -10.6 | Standard Deviation 21.80 | units on a scale | |
| Change From Baseline in Eye Dryness | 0.10% VOS | -9.3 | Standard Deviation 20.00 | units on a scale | |
| Change From Baseline in Eye Dryness | 0.20% VOS | -5.0 | Standard Deviation 17.68 | units on a scale | |
| Change From Baseline in Eye Dryness | Vehicle Ophthalmic Solution | -7.0 | Standard Deviation 17.59 | units on a scale |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.05% Voclosporin Ophthalmic Solution (VOS) | 127 | |
| Overall Study | STARTED | 0.10% VOS | 126 | |
| Overall Study | STARTED | 0.20% VOS | 128 | |
| Overall Study | STARTED | Vehicle Ophthalmic Solution | 127 | |
| Overall Study | Modified Intent to Treat (mITT) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 120 | |
| Overall Study | Modified Intent to Treat (mITT) | 0.10% VOS | 119 | |
| Overall Study | Modified Intent to Treat (mITT) | 0.20% VOS | 122 | |
| Overall Study | Modified Intent to Treat (mITT) | Vehicle Ophthalmic Solution | 121 | |
| Overall Study | COMPLETED | 0.05% Voclosporin Ophthalmic Solution (VOS) | 116 | |
| Overall Study | COMPLETED | 0.10% VOS | 107 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Instillation site pain | General disorders | 0.05% Voclosporin Ophthalmic Solution (VOS) | 29 | 127 | 30 |
| other | Instillation site pain | General disorders | 0.10% VOS | 42 | 126 | 43 |
| other | Instillation site pain | General disorders | 0.20% VOS | 44 | 128 | 47 |
| other | Instillation site pain | General disorders | Vehicle Ophthalmic Solution | 8 | 127 | 10 |
| serious | Carotid artery stenosis | Nervous system disorders | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0 | 127 | 0 |
| serious | Carotid artery stenosis | Nervous system disorders | 0.10% VOS | 0 | 126 | 0 |
| serious | Carotid artery stenosis | Nervous system disorders | 0.20% VOS | 1 | 128 | 1 |
| serious | Carotid artery stenosis | Nervous system disorders | Vehicle Ophthalmic Solution | 0 | 127 | 0 |
| serious | Cerebrovascular accident | Nervous system disorders | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0 | 127 | 0 |
| serious | Cerebrovascular accident | Nervous system disorders | 0.10% VOS | 0 | 126 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0 | 127 |
| Total, all-cause mortality | 0.10% VOS | 1 | 126 |
| Total, all-cause mortality | 0.20% VOS | 0 | 128 |
| Total, all-cause mortality | Vehicle Ophthalmic Solution | 0 | 127 |
| Total, other adverse events | 0.05% Voclosporin Ophthalmic Solution (VOS) | 29 | 127 |
| Total, other adverse events | 0.10% VOS | 42 | 126 |
| Total, other adverse events | 0.20% VOS | 44 | 128 |
| Total, other adverse events | Vehicle Ophthalmic Solution | 8 | 127 |
| Total, serious adverse events | 0.05% Voclosporin Ophthalmic Solution (VOS) | 1 | 127 |
| Total, serious adverse events | 0.10% VOS | 3 | 126 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04147650
GET https://conductscience.org/api/trials/v1/NCT04147650/events?page=2