PURPOSE: Dry eye disease (DED) is common in patients needing cataract surgery and can be further exacerbated in the postoperative period. Perfluorohexyloctane ophthalmic solution (PFHO) is approved for treatment of signs and symptoms of DED. This study evaluated the effects of PFHO treatment before and after cataract surgery in patients with DED.

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 (tCFS), rated on a 0-15 scale; eye dryness, rated on a 100-mm visual analog scale (VAS); Ocular Surface Disease Index (OSDI); root mean square (RMS) higher-order aberrations (HOA) in the central 6.0 mm of the cornea; and visual acuity were assessed before and after each PFHO treatment period.

RESULTS: The study enrolled 97 patients. Mean (SD) tCFS 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 respectively were observed while osdi score improved from 51.9 16.9 to 30.1 17.6 and 11.9 10.9 p><0.001 for all. most patients experienced stable or improved rms hoas after pfho treatment. the percentage of patients with best-corrected visual acuity bcva of 20 20 or better was 86.0 at the first postsurgical assessment and 91.8 after 30 days of subsequent pfho treatment.>

CONCLUSIONS: Presurgical PFHO treatment resulted in statistically significant reductions in signs and symptoms of DED with further improvement after postoperative treatment, including more patients with BCVA of 20/20 or better. These findings support a role for PFHO in pre- and postoperative management of DED in patients undergoing cataract surgery.