Clinical trial NCT03597139: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry Eye
Calcineurin Inhibitors
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
3. 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 \[0-15 scale\]).
4. Have normal lid anatomy.

Exclusion Criteria:

1. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
5. Have used Restasis® for more than 1 month (if prior use is reported).
6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
7. Have had corneal graft surgery in either eye within 1 year.
8. Have recent or current evidence of ocular infection or inflammation in either eye.
9. 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.

Primary outcomes:
measure: Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
timeFrame: 1-minute Post Dose 1 installation (Day 1)
Secondary outcomes:
measure: Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28
timeFrame: Day 28
measure: Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28
timeFrame: Day 28
measure: Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28
timeFrame: 28 days
measure: Change From Baseline in Photophobia Post Dose Instillation on Day 28
timeFrame: 28 days
measure: Change From Baseline in Eye Pain Post Dose Instillation on Day 28
timeFrame: 28 days
measure: Change From Baseline in Eye Dryness Post Dose Instillation on Day 28
timeFrame: 28 days
measure: Change From Baseline in Itching Post Dose Instillation on Day 28
timeFrame: 28 days
measure: Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores
timeFrame: Day 28
measure: Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE)
timeFrame: Day 28
measure: Change From Baseline in Unanesthetized Schirmer Test Score
timeFrame: 28 days
measure: Change From Baseline in Fluorescein Corneal Staining (FCS) Score
timeFrame: 28 days
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Aurinia Investigative Center
state: California
city: Mission Hills
country: United States
facility: Aurinia Investigative Center
state: California
city: Rancho Cordova
country: United States
facility: Aurinia Investigative Center
state: California
city: Kansas City
country: United States
facility: Aurinia Investigative Center
state: Missouri
city: Washington
country: United States
facility: Aurinia Investigative Center
state: Missouri
city: High Point
country: United States
facility: Aurinia Investigative Center
state: North Carolina
city: Memphis
country: United States
facility: Aurinia Investigative Center
state: Tennessee
Study officials:
References: