Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Voclosporin Ophthalmic Solution; Restasis®
Intervention description: Investigational Drug; Comparator
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Calcineurin Inhibitors

Summary:

      Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild
      to moderate Dry Eye Disease (DED).
    

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.