Perfluorohexyloctane eye drops in treating dry eye disease associated with meibomian gland dysfunction: A post‐hoc analysis of responses in subgroups based on symptoms and signs

Aims/Purpose: In a randomized trial of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), patients received either perfluorohexyloctane eye drops ( n = 156) or sodium chloride (NaCl) solution ( n = 156) four times daily. The trial showed that perfluorohexyloctane significantly improved DED signs and symptoms with rapid efficacy and satisfactory safety compared to NaCl. This post hoc analysis evaluated efficacy in subgroups based on signs and symptoms, specifically discordant signs and symptoms. Methods: Patients were grouped according to median changes in total corneal fluorescein staining (tCFS), eye dryness score (EDS), and ocular surface disease index (OSDI) between baseline and day 57 after treatment. Responses at day 57 were defined as: tCFS Response, decrease of ≥ 3 points from baseline; EDS Response, reduction of ≥ 30% from baseline; OSDI Response, reduction of ≥ 30% from baseline. Results: In the tCFS ≤ 6 & EDS ≥ 60 group, the tCFS & EDS Response was 52.7% (29 patients) with perfluorohexyloctane vs. 28.4% (19) with NaCl (OR 95% CI: 2.82, 1.33–5.96, p = 0.0068). In the tCFS > 6 & EDS ≥ 60 group, the tCFS & EDS Response was 72.1% (31) vs. 36.6% (15) (OR 95% CI: 4.48, 1.78–11.25, p = 0.0014). In the tCFS ≤ 6 & OSDI ≥ 60 group, the tCFS & OSDI Response was 61.4% (27) vs. 28.2% (11) (OR 95% CI: 4.58, 1.79–11.74, p = 0.0015). In the tCFS > 6 & OSDI < 60 group, the tCFS & OSDI Response was 72.2% (26) vs. 42.9% (15) (OR 95% CI: 3.47, 1.29–9.33, p = 0.0138). Conclusions: The post hoc analysis showed that perfluorohexyloctane eye drops significantly improved DED symptoms and signs in subgroups where symptoms and signs were discordant, such as those with tCFS ≤ 6 & EDS ≥ 60, tCFS ≤ 6 & OSDI ≥ 60, and tCFS > 6 & OSDI < 60, as well as in cases where both symptoms and signs were more severe, such as tCFS > 6 & EDS ≥ 60.