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Purpose  To assess the safety and efficacy of multi‐ingredient sacha inchi microemulsion ( SIME ) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye.    Methods  This randomized, quadruple‐masked, active‐controlled parallel study in 64 adult patients comprised three parts. Part 1 ( n  = 3): one eye was treated with  SIME  for one day. Part 2 ( n  = 9): randomized eyes were treated with  SIME  and 0.2% hyaluronic acid ( HA ) control eye drops 3 times a day for 10 days. Part 3 ( n  = 26 + 26): randomized treatment was applied on both eyes 3 times a day for 30 days.  OSDI  change was tested for superiority of  SIME  over  HA . Ocular assessments were performed at baseline and after the last dose.    Results  Both treatments were well tolerated without adverse device effects. Tear film break‐up time (p = 0.0025) and ocular protection index (p = 0.0026; change vs.  HA , p = 0.047) increased significantly with  SIME  after 30 days. Tear osmolarity decreased more in  SIME  than in the  HA  group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p = 0.014) and nasal conjunctival staining (p = 0.043) were reduced with  SIME  in per‐protocol patients ( n  = 24). Conjunctival (p = 0.001) and lid redness (p = 0.012) decreased with  SIME  in all patients ( n  = 26). Symptoms decreased by about 25  OSDI  units with both treatments (p < 0.0001) and with nonsignificant difference between treatments.    Conclusions  Sacha inchi microemulsion (SIME) proved safe and efficacious in improving each aetiologic factor for dry eye as revealed through objective tests. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.

acta ophthalmologica

Disease aetiology‐based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple‐masked and active‐controlled clinical trial