Efficacy and safety of perfluorohexyloctane eye drops in ametropic patients with dry eye disease associated with meibomian gland dysfunction: A subgroup analysis from a phase 3 clinical trial

Aims/Purpose: The randomized clinical trial demonstrated the efficacy and safety of perfluorohexyloctane (SHR8058) eye drops for dry eye disease (DED) associated with meibomian gland dysfunction (MGD). This post‐hoc analysis aimed to evaluate the efficacy and safety of perfluorohexyloctane eye drops in ametropic patients with DED associated with MGD. Methods: This subgroup analysis based on a randomized, double‐masked, saline‐controlled, phase 3 trial included ametropic patients with DED and MGD. In the original study, participants were randomized to receive either perfluorohexyloctane or 0.6% sodium chloride (NaCl) drops four times daily for 57 days. Primary endpoints were changes in total corneal fluorescein staining (tCFS) and eye dryness score at day 57. Results: A total of 121 ametropic patients were included (57 in the perfluorohexyloctane group, 64 in the NaCl group). At day 57, the perfluorohexyloctane group showed a significant improvement in tCFS score (mean reduction: −5.2) vs. NaCl (mean reduction: −3.3), with an estimated least squares mean (LSmean) difference of −1.9 (95% CI: −2.7 to −1.1). Eye dryness score improved significantly in the perfluorohexyloctane group (mean reduction: −42.4) vs. NaCl (mean reduction: −26.9), with an estimated LSmean difference of −15.5 (95% CI: −22.1 to −8.8). Additionally, perfluorohexyloctane eye drops alleviated symptoms including pain, awareness of DED symptoms, and frequency of dryness compared to the control. Ocular treatment‐emergent adverse events were similar between groups (15.8% in the perfluorohexyloctane group vs. 14.1% in the NaCl group). Conclusions: Perfluorohexyloctane eye drops significantly improved both objective signs and subjective symptoms of DED in ametropy patients with MGD, demonstrating favorable efficacy and safety.