Phase 2
N=100
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03597139 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1 — 7.9; 3.5 mm — p=0.1491
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Voclosporin Ophthalmic Solution (Drug); Restasis® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1 |
7.9; 3.5 | 0.1491 |
| SECONDARY Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28 |
11.8; 6.1 | 0.1187 |
| SECONDARY Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28 |
-12.3; -20.1 | 0.2128 |
| SECONDARY Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28 |
-19.7; -20.7 | 0.8408 |
| SECONDARY Change From Baseline in Photophobia Post Dose Instillation on Day 28 |
-23.1; -26.2 | 0.5356 |
| SECONDARY Change From Baseline in Eye Pain Post Dose Instillation on Day 28 |
-13.9; -19.9 | 0.1787 |
| SECONDARY Change From Baseline in Eye Dryness Post Dose Instillation on Day 28 |
-35.0; -34.6 | 0.7666 |
| SECONDARY Change From Baseline in Itching Post Dose Instillation on Day 28 |
-26.9; -28.1 | 0.8082 |
| SECONDARY Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores |
-130.9; -149.6 | 0.6362 |
| SECONDARY Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE) |
-28.0; -37.9; -24.9; -36.1 | 0.0961 |
| SECONDARY Change From Baseline in Unanesthetized Schirmer Test Score |
8.5; 3.0; 8.2; 3.3 | 0.0051 sig |
| SECONDARY Change From Baseline in Fluorescein Corneal Staining (FCS) Score |
-2.2; -0.2; -2.2; -0.7 | 0.0003 sig |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03597139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.