Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial.

Purpose: Sex hormone changes, often occurring during menopause, are implicated in meibomian gland dysfunction (MGD) and evaporative dry eye disease (DED). This study aimed to evaluate whether menopausal status affects the treatment outcomes of perfluorohexyloctane eye drops.

Methods: This post hoc analysis used data from a phase 3 trial (NCT05515471) of perfluorohexyloctane eye drops in patients with DED associated with MGD. The efficacy and safety of perfluorohexyloctane compared with 0.6% saline were evaluated within each menopausal status subgroup (premenopausal or postmenopausal), and the interaction between treatment and menopausal status was assessed.

Results: In total, 245 women (94 postmenopausal and 151 premenopausal) were included. In the postmenopausal subgroup, the propensity score weighted least-squares mean differences (LSMD) in changes from baseline to day 57 in total corneal fluorescein staining (tCFS) score and eye dryness score (EDS) between perfluorohexyloctane and saline were -1.0 (95% CI, -2.0, 0.0) and -7.9 (95% CI, -15.6, -0.2), respectively. In the premenopausal subgroup, the propensity score weighted LSMD in changes from baseline to day 57 in tCFS score and EDS were -1.4 (95% CI, -2.3, -0.5) and -14.0 (95% CI, -20.3, -7.8), respectively. Both subgroups showed improvements in some DED symptoms. No statistically significant interaction was observed between menopausal status and treatment across all measured outcomes. Perfluorohexyloctane was well tolerable in both subgroups.

Conclusions: Perfluorohexyloctane eye drops improved signs and symptoms of DED associated with MGD and were safe in both postmenopausal and premenopausal women. Further studies are needed to confirm the influence of menopausal status on perfluorohexyloctane efficacy.

Trial registration: ClinicalTrials.gov identifier, NCT05515471.