A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease
| Autor: | Tauber, Joseph, Evans, David, Segal, Bruce, Li, Xiao-Yan, Shen, Wang, Lu, Caroline, Novack, Gary D, VVN001-CS201 Study Group |
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| Rok vydání: | 2022 |
| Předmět: |
Cornea
VVN001-CS201 Study Group VVN001 Clinical Research Opthalmology and Optometry 6.1 Pharmaceuticals Symptoms Clinical Trials and Supportive Activities Evaluation of treatments and therapeutic interventions Dry eye disease Patient Safety Ophthalmology & Optometry Eye Disease and Disorders of Vision |
| Popis: | PurposeEvaluate the initial ocular safety and tolerability and efficacy of VVN001 Ophthalmic Solution (VVN001), a small-molecule antagonist of lymphocyte function-associated antigen-1 (LFA-1), in subjects with dry eye disease (DED).MethodsThis was a multi-center, double-masked, randomized, dose-response, vehicle-controlled, parallel-group study conducted in 170 subjects with DED. Subjects were randomized to receive VVN001 (1% or 5%) or its vehicle, twice-daily in both eyes for 84 days. The primary outcome measure was inferior region corneal fluorescein staining (iCFS, 0-4 scale) at Day 84. Visual Analogue Scale eye dryness (VAS, 0-100 scale) was a secondary outcome.ResultsThe primary and first secondary outcomes were not met. At Day 84 treatment effects in favor of VVN001 5% relative to its vehicle for iCFS were 0.29 units (p=0.054), and for VAS were 3.18 units (p=0.533). In other secondary outcomes, treatment effects in favor of VVN001 5% relative to its vehicle were seen in total CFS (1.61 units, 0-20 scale, p=0.004) and Schirmer score (1.77 and 2.32mm, p=0.049 and p=0.17atDays 14 and 28 respectively). Adverse events of incidence 5% or greater in either active treatment group were instillation site pain (3/57, 5.3%), dysgeusia (3/56, 5.4%) and urinary tract infection (3/57, 5.3%).ConclusionsThere were no major safety issues of note. Appropriately powered studies will be required with a priori selection of the efficacy endpoints to evaluate VVN001's therapeutic potential. |
| Databáze: | OpenAIRE |
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