A Phase 2/3 interventional study of 0.05% Voclosporin Ophthalmic Solution (VOS) and 0.10% VOS in Dry Eye Syndrome and Keratoconjunctivitis Sicca, sponsored by Aurinia Pharmaceuticals Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by Aurinia Pharmaceuticals Inc. · Phase 2/3, Interventional, and Treatment
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.
This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 508 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Aurinia Pharmaceuticals Inc. is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Drug: 0.10% VOS
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Drug: 0.20% VOS
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
Drug: Vehicle Ophthalmic Solution
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
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.
Time frame: 4 Weeks
Change From Baseline in Eye Dryness
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."
Time frame: Value at 4 Weeks minus value at baseline
| Milestone | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|
| Started | 127 | 126 | 128 | 127 |
| Modified intent to treat (mitt) | 120 | 119 | 122 | 121 |
| Completed | 116 | 107 | 121 | 120 |
| Not completed | 11 | 19 | 7 | 7 |
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.
| participants | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | 12 | 10 | 13 | 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."
| units on a scale | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|
| Change From Baseline in Eye Dryness | -10.6 ± 21.80 | -9.3 ± 20.00 | -5.0 ± 17.68 | -7.0 ± 17.59 |
Collected over Day 1 to Week 13. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | 0/127 (0%) | 1/127 (0.8%) | 29/127 (22.8%) |
| 0.10% VOS | 1/126 (0.8%) | 3/126 (2.4%) | 42/126 (33.3%) |
| 0.20% VOS | 0/128 (0%) | 2/128 (1.6%) | 44/128 (34.4%) |
| Vehicle Ophthalmic Solution | 0/127 (0%) | 3/127 (2.4%) | 8/127 (6.3%) |
| Event | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 0/127 | 1/126 | 0/128 | 0/127 |
| Myocardial infarctionCardiac disorders | 0/127 | 1/126 | 0/128 | 0/127 |
| Small intestinal obstructionGastrointestinal disorders | 0/127 | 1/126 | 0/128 | 0/127 |
| Head injuryInjury, poisoning and procedural complications | 0/127 | 0/126 | 0/128 | 1/127 |
| Systemic inflammatory response syndromeGeneral disorders | 1/127 | 0/126 | 0/128 | 0/127 |
| AppendicitisInfections and infestations | 0/127 | 0/126 | 0/128 | 1/127 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/127 | 0/126 | 0/128 | 1/127 |
| Carotid artery stenosisNervous system disorders | 0/127 | 0/126 | 1/128 | 0/127 |
| Cerebrovascular accidentNervous system disorders | 0/127 | 0/126 | 1/128 | 0/127 |
| Fluid overloadMetabolism and nutrition disorders | 0/127 | 0/126 | 1/128 | 0/127 |
| Event | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution |
|---|---|---|---|---|
| Instillation site painGeneral disorders | 29/127 | 42/126 | 44/128 | 8/127 |
| Age, Continuous(years) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| Mean | 63.3 ± 11.82 | 64.2 ± 11.27 | 64.8 ± 10.47 | 64.1 ± 12.43 | 64.1 ± 11.49 |
| Age, Continuous(years) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| Median | 64 (25 to 86) | 65 (30 to 84) | 65 (28 to 89) | 65 (27 to 94) | 65 (25 to 94) |
| Sex: Female, Male(Participants) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| Female | 96 | 91 | 88 | 97 | 372 |
| Male | 31 | 35 | 40 | 30 | 136 |
| Ethnicity (NIH/OMB)(Participants) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 7 | 6 | 25 |
| Not Hispanic or Latino | 120 | 120 | 121 | 121 | 482 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 0.05% Voclosporin Ophthalmic Solution (VOS) | 0.10% VOS | 0.20% VOS | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 1 | 4 |
| Asian | 7 | 5 | 9 | 10 | 31 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 | 2 |
| Black or African American | 17 | 16 | 17 | 22 | 72 |
| White | 96 | 103 | 99 | 91 | 389 |
| More than one race | 4 | 1 | 3 | 2 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Voclosporin
Aurinia Pharmaceuticals Inc.