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

Mean OSDI sum score decreased with both SIME ( − 51%) and HA control eye drops ( − 58%) from baseline (ITT data set), most patients reporting mild or nonexistent residual symptoms on Day 30 (medians 17 and 14, respectively); both of these within‐group changes were highly significant (p < 0.0001) for PP and ITT populations but lacking significance between treatments (Fig.

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Similarly, SIME reduced conjunctival staining with statistical significance in the nasal conjunctiva of PP subjects (−22%, p = 0.043) and with marginal significance in ITT subjects (−19%, p = 0.059) (Fig.

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OPI improved significantly by 57% to about 1.5 OPI units with SIME (p = 0.0026) and by 4% with HA; treatment difference in changes from baseline was statistically significant for ITT population (p = 0.047) and marginally significant for PP population (p = 0.071) in favour of SIME (Fig.

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