Factors associated with the speed of response to perfluorohexyloctane eye drops (SHR8058) in dry eye disease associated with meibomian gland dysfunction: A post‐hoc analysis of a randomised, phase 3 trial

Aim: In a randomised, double‐masked, phase 3 trial, perfluorohexyloctane eye drops (SHR8058) significantly improved signs and symptoms compared to 0.6% sodium chloride (NaCl) in patients (pts) with dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Here, we present a post‐hoc analysis of this phase 3 trial to identify factors associated with the speed of sign and symptom responses to SHR8058. Methods: Adult pts with DED associated with MGD were randomized 1: 1 to receive SHR8058 or 0.6% NaCl 4 times daily for 57 days. In this post‐hoc analysis, pts were divided into rapid‐ and non‐rapid‐response groups based on the speed of sign or symptom response to SHR8058. Rapid response was defined as a response in total corneal fluorescein staining (tCFS) scores ( ≥ 3 reduction from baseline) at day 29 for signs and in eye dryness scores (EDS, ≥ 30% reduction from baseline) at day 15 for symptoms. Results: A total of 143 pts who responded to SHR8058 in either signs or symptoms were included in this analysis, with 90 pts in the rapid‐response group for signs and 51 for symptoms. Univariate logistic regression analysis showed that baseline tCFS score (OR 1.4, 90% CI 1.06–1.74, p = 0.040) was significantly associated with a rapid response for signs, and none of the other baseline factors showed an association (all p > 0.05), including age, sex, DED‐related eye symptoms, EDS, sticky feeling, burning/stinging sensation, foreign body sensation, itchiness, blurred vision, sensitivity to light, pain, awareness of DED symptoms, frequency of dryness, ocular surface disease index scores, tear film breakup time, MGD scores, Schirmer I test results, menopause and refractive error. However, none of the above factors were correlated with rapid response for symptoms (all p > 0.05). Conclusions: In pts with DED associated with MGD, baseline tCFS score is markedly associated with sign response speed to SHR8058, whereas no baseline factor shows an association with symptom response speed.