PURPOSE: Dry eye disease (DED) is common in patients undergoing cataract surgery and can be further exacerbated in the postoperative period. Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to decrease tear evaporation and is approved for treatment of signs and symptoms of DED. The aim of this study was to evaluate the effects of treatment with PFHO in patients with DED before and after cataract surgery.

METHODS: This prospective, multicenter, open-label, phase 4 study (NCT06346340) enrolled patients with DED who were candidates for phacoemulsification with posterior chamber intraocular lens (IOL) implantation. Patients instilled PFHO in both eyes QID for 30 days preoperatively and received a second 30-day PFHO treatment beginning approximately 1 month after surgery. Total corneal fluorescein staining (CFS, rated on a 0-15 scale), eye dryness (rated on a 100-mm visual analog scale [VAS]), Ocular Surface Disease Index (OSDI), and visual acuity were assessed before and after each PFHO treatment period. The 30-day postoperative standard-of-care visit also included assessment of refractive outcome (manifest refraction).

RESULTS: The study enrolled 97 patients (75.3% female; mean age, 68.6 years). Mean (SD) total CFS score improved from 5.0 (2.7) to 2.1 (2.2) and 1.3 (1.8) after the first and second 30-day PFHO treatments, respectively (P<0.001 for both. reductions from baseline in eye dryness vas score from 62.3 19.0 to 37.5 23.1 and 25.9 23.3 were observed after the first and second pfho treatment respectively while osdi score improved from 51.9 16.9 to 30.1 17.6 and 11.9 10.9 p><0.001 for all. the mean difference between absolute deviations in predicted refractive error measured before and after the presurgery pfho treatment was -0.027. at the end of the study best corrected visual acuity snellen was 20 20 or better in 91.8 of patients. two adverse events were considered related to treatment eye pruritus and noninfective conjunctivitis both were rated as mild in severity.>

CONCLUSION: In this study, presurgical PFHO treatment resulted in statistically significant reductions in signs and symptoms of DED with continued improvements in the postoperative period, demonstrating the utility of this agent in patients with DED undergoing cataract surgery.