Perfluorohexyloctane eye drops in treating dry eye disease associated with meibomian gland dysfunction: a post hoc analysis by baseline severity

This post hoc analysis aimed to explore the effect of perfluorohexyloctane on dry eye disease (DED) associated with meibomian gland dysfunction (MGD) by baseline disease severity. Data from a randomized phase 3 trial (NCT05515471) were divided based on the baseline severity of DED signs (total corneal fluorescein staining tCFS score: < 6 or ≥ 6; tear film breakup time: < 3 or ≥ 3; MGD score: < 7 or ≥ 7) or symptoms (eye dryness scores EDS: < 70 or ≥ 70; ocular surface disease index score: < 60 or ≥ 60). The main outcomes of interest included response rates at day 57 of tCFS score, EDS, and tCFS and EDS, safety, and tolerability. Participants treated with perfluorohexyloctane had greater odds of achieving EDS (odds ratio OR: 2.25; 95% confidence interval CI: 1.34, 3.80), tCFS (OR: 2.21; 95% CI: 1.38, 3.55), and tCFS and EDS (OR: 2.56; 95% CI: 1.62, 4.04) responses than those treated with 0.6% sodium chloride in the overall population. No significant treatment interaction effect was observed by any DED signs or symptoms except for a significant effect of baseline tCFS score on EDS response, with a relatively large effect in participants with tCFS ≥ 6 versus tCFS < 6 (propensity score-weighted OR: 4.35 versus 1.26; Pinteraction = 0.0317). The safety and tolerability profiles of perfluorohexyloctane stratified by baseline disease severity were generally consistent. Perfluorohexyloctane was well tolerated and improved the signs and symptoms of DED associated with MGD in patients with different baseline disease severity compared to saline control.