PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient perceptions and satisfaction 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, tear film breakup time (TFBUT) ≤5 seconds, Schirmer I test (without anesthesia) score ≥5 mm, Meibomian Gland Dysfunction (MGD) score ≥3 (range, 0-15), and total corneal fluorescein staining (tCFS) score ≥4 and ≤11 (range, 0-15). PFHO was instilled in both eyes 4 times daily for 14 days. Patients completed early outcome surveys during four clinic visits. The early outcomes survey assessed DED symptom severity (8 symptoms), symptom frequency (percentage of time experiencing the symptom), and treatment satisfaction (rated on a visual analog scale from 0-100). Change in symptom frequency from baseline at each post-baseline assessment was analyzed using a 2-sided paired t-test.

RESULTS: A total of 99 patients were enrolled. Mean age was 61.3 years; 85.9% of patients were female. At baseline, mean scores (both eyes) on ocular measures were: TFBUT, 3.6 seconds; Schirmer test, 14.2 mm; MGD score, 8.3; and tCFS, 5.2. The symptom selected as "most bothersome" at baseline was eye dryness (28.3% of patients), blurred vision (17.2%), eye irritation (14.1%), light sensitivity (13.1%), eye tiredness (12.1%), burning/stinging (11.1%), eye itching (4.0%), or eye pain (0%). Mean frequency (percentage of time) experiencing the most bothersome symptom was 77.9% at baseline and decreased to 46.7% at day 3, 41.3% at day 7, and 34.7% at day 14 (a mean reduction of 40.0%, 47.0%, and 55.5%, respectively). Reduction in most bothersome symptom frequency was statistically significant (P<0.0001) at every follow-up assessment. median rating of treatment satisfaction was 83.0 at day 3 86.0 at day 7 and 90.0 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. Treatment satisfaction with PFHO was high.