PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient-reported symptoms early in treatment with PFHO.

METHODS: This prospective, multicenter, open-label, phase 4 study (NCT06309953) enrolled adults with a history of DED for ≥6 months. PFHO was instilled in both eyes 4 times daily for 14 days. Patients completed early outcome surveys during 4 clinic visits (baseline and days 3, 7, and 14). The primary outcome (symptom severity) is presented separately. Secondary outcomes included patient-reported frequency (percentage of time experiencing) of the most bothersome symptom, awareness of dry eye symptoms, and fluctuations in quality of vision.

RESULTS: The "most bothersome" symptom at baseline (n=99 patients) was eye dryness (28.3%), blurred vision (17.2%), eye irritation (14.1%), light sensitivity (13.1%), eye tiredness (12.1%), burning/stinging (11.1%), or eye itching (4.0%). Mean frequency (percentage of time) experiencing the most bothersome symptom decreased significantly (P<0.0001) from 77.9 at baseline to 46.7 at day 3 41.3 at day 7 and 34.7 at day 14. significant p><0.0001) decreases were also observed in mean frequency of awareness of dry eye symptoms 77.6 at baseline 39.7 at day 3 32.6 at day 7 27.6 at day 14 and fluctuations in quality of vision 62.8 at baseline 29.8 at day 3 24.5 at day 7 19.4 at day 14.>

CONCLUSIONS: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in the frequency of dry eye symptoms, including the patient-specific most bothersome symptom.