Summary
PURPOSE: In randomized controlled trials, perfluorohexyloctane ophthalmic solution (PFHO) was superior to a hypotonic saline control for reducing signs and symptoms of dry eye disease (DED) at the first evaluation time point (Day 15) and the primary endpoint (Day 57). The aim of this study was to evaluate early treatment effects of PFHO.
METHODS: In this prospective, multicenter, open-label, phase 4 study (NCT06309953), adults with DED instilled PFHO in both eyes QID for 14 days and completed outcome surveys during 4 clinic visits (Day 1 [pretreatment; 5 and 60 min post-PFHO instillation] and Days 3, 7, and 14). The surveys evaluated symptom severity for overall dry eye symptoms and for 8 individual symptoms using a visual analog scale (range, 0-100). Treatment response was defined as score reduction ≥30% from pretreatment baseline.
RESULTS: In 99 enrolled patients (female, 85.9%; age range, 35-81 years), responder rates for overall dry eye symptoms were 68.7% at 5 minutes post-instillation, 76.5% at 60 minutes post-instillation, 73.7% at Day 3, 85.7% at Day 7, and 83.7% at Day 14. High responder rates were also observed at all timepoints for all individual symptoms evaluated including Day 7 responder rates of 85.7% for eye dryness, 81.6% for eye irritation, 78.6% for burning/stinging, 75.5% for light sensitivity, 75.5% for eye pain, 74.5% for eye tiredness, 71.4% for eye itching, and 68.4% for blurred vision.
CONCLUSION: In patients with DED, clinically meaningful improvements in symptoms were observed in a high percentage of patients starting as early as 5 minutes post-instillation and continuing during the first 2 weeks of PFHO treatment.