Back to resultsOcular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Voclosporin Ophthalmic Solution
Restasis®
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Calcineurin Inhibitors
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Aurinia Investigative Center
- Aurinia Investigative Center
- Aurinia Investigative Center
- Aurinia Investigative Center
- Aurinia Investigative Center
- Aurinia Investigative Center
- Aurinia Investigative Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Voclosporin ophthalmic solution (VOS)
Comparator
Arm Description
0.2% VOS, Twice Daily (BID), both eyes for 28 days
0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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".
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".
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".
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".
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".
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".
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".
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).
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.
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.
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.
Full Information
NCT ID
NCT03597139
First Posted
July 13, 2018
Last Updated
July 5, 2021
Sponsor
Aurinia Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03597139
Brief Title
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurinia Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Calcineurin Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voclosporin ophthalmic solution (VOS)
Arm Type
Experimental
Arm Description
0.2% VOS, Twice Daily (BID), both eyes for 28 days
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days
Intervention Type
Drug
Intervention Name(s)
Voclosporin Ophthalmic Solution
Other Intervention Name(s)
0.2% VOS
Intervention Description
Investigational Drug
Intervention Type
Drug
Intervention Name(s)
Restasis®
Other Intervention Name(s)
RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
Description
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".
Time Frame
1-minute Post Dose 1 installation (Day 1)
Secondary Outcome Measure Information:
Title
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28
Description
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".
Time Frame
Day 28
Title
Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28
Description
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".
Time Frame
Day 28
Title
Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28
Description
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".
Time Frame
28 days
Title
Change From Baseline in Photophobia Post Dose Instillation on Day 28
Description
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".
Time Frame
28 days
Title
Change From Baseline in Eye Pain Post Dose Instillation on Day 28
Description
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".
Time Frame
28 days
Title
Change From Baseline in Eye Dryness Post Dose Instillation on Day 28
Description
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".
Time Frame
28 days
Title
Change From Baseline in Itching Post Dose Instillation on Day 28
Description
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".
Time Frame
28 days
Title
Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores
Description
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).
Time Frame
Day 28
Title
Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE)
Description
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.
Time Frame
Day 28
Title
Change From Baseline in Unanesthetized Schirmer Test Score
Description
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.
Time Frame
28 days
Title
Change From Baseline in Fluorescein Corneal Staining (FCS) Score
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Aurinia Investigative Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Aurinia Investigative Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Aurinia Investigative Center
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Aurinia Investigative Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Aurinia Investigative Center
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Aurinia Investigative Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Aurinia Investigative Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
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