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Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Phase 2, PHASE3 trial testing 0.05% Voclosporin Ophthalmic Solution (VOS) in Dry Eye Syndrome in 508 participants. Completed in 8 October 2020.
| Lead sponsor | Aurinia Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 508 |
| Start date | 14 October 2019 |
| Primary completion | 17 September 2020 |
| Estimated completion | 8 October 2020 |
| Sites | 9 locations across United States |
Aurinia Pharmaceuticals Inc. — full company profile →
18 and older, any sex, with Dry Eye Syndrome or Keratoconjunctivitis Sicca. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | 12 | |
| 0.10% VOS | 10 | |
| 0.20% VOS | 13 | |
| Vehicle Ophthalmic Solution | 6 |
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."
| Group | Value | 95% CI |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | -10.6 | ± 21.80 |
| 0.10% VOS | -9.3 | ± 20.00 |
| 0.20% VOS | -5.0 | ± 17.68 |
| Vehicle Ophthalmic Solution | -7.0 | ± 17.59 |
Time frame: Day 1 to Week 13. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 0.05% Voclosporin Ophthalm… | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|---|
| Carotid artery stenosis | Nervous system disorders | — | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — | — |
| Fluid overload | Metabolism and nutrition disorders | — | — | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Head injury | Injury, poisoning and procedural complications | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Systemic inflammatory response syndrome | General disorders | — | — | — | — |
| Appendicitis | Infections and infestations | — | — | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | 0.05% Voclosporin Ophthalm… | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | — | — | — | — |
Most-reported serious reactions: Carotid artery stenosis, Cerebrovascular accident, Fluid overload, Femur fracture, Head injury, Myocardial infarction, Small intestinal obstruction, Systemic inflammatory response syndrome.
Data from ClinicalTrials.gov NCT04147650 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing