Dry EyePhase 2NCT03597139
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
A Phase 2 study testing Voclosporin Ophthalmic Solution and Restasis® in people with Dry Eye, run by Aurinia Pharmaceuticals Inc. at 7 sites in United States.
Trial summary
Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Voclosporin Ophthalmic Solution and Restasis®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Aug 2018to 13 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
- Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:
- A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
- An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
- Evidence of ocular surface staining (total fluorescein staining score of at least 3 [0-15 scale]).
- Have normal lid anatomy.
Who cannot join
- Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
- Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
- Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
- Have used Restasis® for more than 1 month (if prior use is reported).
- Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
Show all 9Show fewer
- Have had corneal graft surgery in either eye within 1 year.
- Have recent or current evidence of ocular infection or inflammation in either eye.
- Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Aurinia Investigative Center
Garden Grove, California, 92843
Aurinia Investigative Center
High Point, North Carolina, 27262
Aurinia Investigative Center
Kansas City, Missouri, 64111
Aurinia Investigative Center
Memphis, Tennessee, 38119
Aurinia Investigative Center
Mission Hills, California, 91345
Aurinia Investigative Center
Rancho Cordova, California, 95670
Aurinia Investigative Center
Washington, Missouri, 63090
About this study
Official title: An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).
Read the detailed description
This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US
- Conditions
- Dry Eye
- Being tested
- Voclosporin Ophthalmic Solution, Restasis®
- Keywords
- Dry Eye, Calcineurin Inhibitors
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voclosporin Ophthalmic SolutionDrug
Also called 0.2% VOS
Investigational Drug
Restasis®Drug
Also called RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%
Comparator
| Study group | Role | What they receive |
|---|---|---|
| Voclosporin ophthalmic solution (VOS) | Experimental | 0.2% VOS, Twice Daily (BID), both eyes for 28 days Receives: Drug: Voclosporin Ophthalmic Solution |
| Comparator | Active comparator | 0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days Receives: Drug: Restasis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".
Measured: 1-minute Post Dose 1 installation (Day 1)
Secondary outcomes (11)
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28
Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".
Measured: Day 28
Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28
Burning/Stinging was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no burning/stinging" and 100 corresponds to "worst burning/stinging".
Measured: Day 28
Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28
Foreign Body Sensation was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no foreign body sensation" and 100 corresponds to "worst foreign body sensation".
Measured: 28 days
Change From Baseline in Photophobia Post Dose Instillation on Day 28
Photophobia was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no photophobia" and 100 corresponds to "worst photophobia".
Measured: 28 days
Change From Baseline in Eye Pain Post Dose Instillation on Day 28
Eye pain was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no eye pain" and 100 corresponds to "worst eye pain".
Measured: 28 days
Change From Baseline in Eye Dryness Post Dose Instillation on Day 28
Eye dryness was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no eye dryness" and 100 corresponds to "worst eye dryness".
Measured: 28 days
Change From Baseline in Itching Post Dose Instillation on Day 28
Itching was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment post-instillation on Day 28. The VAS scale is 0 - 100, where 0 corresponds to "no itching" and 100 corresponds to "worst itching".
Measured: 28 days
Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores
The Individual Symptom Severity Assessment Visual Analog Scale (VAS) includes Burning/Stinging (scale 0 - 100; 0 = no Burning/Stinging, 100 = worst Burning/Stinging), Foreign Body Sensation (scale 0 - 100; 0 = no Foreign Body Sensation, 100 = worst Foreign Body Sensation), Photophobia (scale 0 - 100; 0 = no Photophobia, 100 = worst Photophobia), Eye Pain (scale 0 - 100; 0 = no Eye Pain, 100 = worst Eye Pain), Eye Dryness (scale 0 - 100; 0 = no Eye Dryness, 100 = worst Eye Dryness), and Itching (scale 0 - 100; 0 = no Itching, 100 = worst Itching). The total sum of all 6 symptoms (Burning/Stinging, Foreign Body Sensation, Photophobia, Eye Pain, Eye Dryness, Itching) were evaluated (scale 0 - 600; 0 = no visual symptoms, 600 = worst visual symptoms).
Measured: Day 28
Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE)
The Symptom Assessment in Dry Eye (SANDE) is a subjective rating performed by the subjects for the frequency and severity of their dry eye symptoms. The total length of the line is 100mm. For Frequency of Symptoms 0mm = "rarely" and 100mm = "all the time". For Severity of Symptoms 0mm = "very mild" and 100mm = "very severe". Subjects were asked to subjectively rate the frequency and severity of their symptoms by placing an "X" on the relevant horizontal line. The length of the line between the "rarely" or "very mild" starting point and the first point where the subject's mark crosses each line was measured and recorded in millimeters.
Measured: Day 28
Change From Baseline in Unanesthetized Schirmer Test Score
The Schirmer Test Score recorded tear production on test strips. The Schirmer tear test was conducted 1 hour following administration of VOS/Comparator and 20 minutes following fluorescein corneal staining. Using a ruler and/or the millimeters recorded on the strips, a point halfway between the two lines was measured and this was recorded as the amount of wetting. Lower scores indicate less tear production and therefore a worse outcome. Normal tear production is ≥10mm of wetting on the test strip, and severe dry eye is <5mm of wetting on the test strip.
Measured: 28 days
Change From Baseline in Fluorescein Corneal Staining (FCS) Score
The FCS score was summarized for each eye separately. Each of the 5 sections of cornea (superior, inferior, nasal, temporal, central) were graded using the National Eye Institute (NEI) scale; 0, 1 (mild), 2 (moderate), or 3 (severe). The total score was obtained by summing each of the 5 sections of the cornea from 0 - 15. Lower scores indicate less staining and therefore a better outcome.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start13 Aug 2018
- Primary completion9 Nov 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597139
- Sponsor's protocol ID
- AUR-VOS-2017-01
- Status last verified
- May 2021
- First submitted
- 13 Jul 2018
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03597139
- Acronym / sponsor ID
- AUR-VOS-2017-01
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Calcineurin Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).
Detailed description
This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US.
| Arm | Type | Receives |
|---|---|---|
| Voclosporin ophthalmic solution (VOS) | Experimental | Drug: Voclosporin Ophthalmic Solution0.2% VOS, Twice Daily (BID), both eyes for 28 days |
| Comparator | Active comparator | Drug: Restasis®0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
- Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:
- Have normal lid anatomy.
Key exclusion criteria (9 listed)
- Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
- Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
- Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
- Have used Restasis® for more than 1 month (if prior use is reported).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voclosporin Ophthalmic SolutionAlso: 0.2% VOSInvestigational Drug | Drug | Voclosporin ophthalmic solution (VOS) |
| Restasis®Also: RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%Comparator | Drug | Comparator |
Primary outcome
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
Time frame: 1-minute Post Dose 1 installation (Day 1)
Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".
11 secondary outcomes
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28
Time frame: Day 28
Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28
Time frame: Day 28
Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28
Time frame: 28 days
Change From Baseline in Photophobia Post Dose Instillation on Day 28
Time frame: 28 days
Change From Baseline in Eye Pain Post Dose Instillation on Day 28
Time frame: 28 days
Change From Baseline in Eye Dryness Post Dose Instillation on Day 28
Time frame: 28 days
Change From Baseline in Itching Post Dose Instillation on Day 28
Time frame: 28 days
Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores
Time frame: Day 28
Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE)
Time frame: Day 28
Change From Baseline in Unanesthetized Schirmer Test Score
Time frame: 28 days
Change From Baseline in Fluorescein Corneal Staining (FCS) Score
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Voclosporin Ophthalmic Solution and Restasis® in people with Dry Eye, run by Aurinia Pharmaceuticals Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1 (time frame: 1-minute Post Dose 1 installation (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.