In a randomized, triple-blind, phase II clinical trial, investigators sought to determine the effectiveness of a subconjunctival novel sirolimus liposomal formulation for treating dry eye. The study, which included 19 patients (38 eyes), assigned nine patients (18 eyes) to a sham treatment group and 10 patients (20 eyes) to a sirolimus-loaded liposomes group. The study team assessed subjective (Ocular Surface Disease Index [OSDI]) and objective (corrected distance visual acuity, conjunctival hyperemia, tear osmolarity, Schirmer test, corneal/conjunctival staining, and matrix metalloproteinase-9) variables. Changes in OSDI scores decreased from 62.19 to 37.8 (P=.0024) in the sirolimus treatment group and from 60.02 to 36.02 (P=.01) in the sham treatment group. Significant changes for all other outcomes examined were observed only in the sirolimus group: corneal/conjunctival staining score (P=.0015), lipid layer interferometry (P=.006), and inferior meibomian gland dropout (P=.038). The results indicate that subconjunctival sirolimus could be effective in decreasing signs and symptoms of dry eye in patients, according to the researchers.
