Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
Laura Levy, DHSc, PA-C
Objective: The objective of this selective EBM review is to determine whether or not lifitegrast 5.0% ophthalmic solution is effective in improving eye dryness and safe, in terms of ocular adverse effects, in adults 18 years or older with dry eye disease (DED).
Study Design: Systematic review of three primary double-blinded, randomized placebocontrolled trials that were published in peer-reviewed journals between 2014-2017.
Data Sources: Studies were obtained through the PubMed database based on relevance to the clinical question and evaluation of patient-oriented outcomes.
Outcomes Measured: Efficacy of lifitegrast treatment was measured based on the eye dryness score (EDS) obtained from a subject-reported symptom assessment using a 7-item visual analog scale. Safety of treatment was measured through investigator safety assessments and recording of adverse events conducted at study visits.
Results: All three analyzed randomized control trials showed a greater reduction in the EDS with lifitegrast 5.0% ophthalmic solution compared to placebo. In Holland et al., the reduction in the EDS was 10.7% greater with lifitegrast compared to placebo (p=0.0007). In Sheppard et al., the reduction was 17.8% greater with lifitegrast (p=0.0291). In Tauber et al., lifitegrast showed a 12.3% greater reduction (p<0.0001). For the safety assessment, lifitegrast had more ocular adverse effects (OAE) than placebo, with majority being mild to moderate in severity. In Holland et al., 39.5% who received lifitegrast had OAE in comparison to 17.8% who received placebo. In Sheppard et al., 33.7% with lifitegrast had OAE compared to 16.4% with placebo. In Tauber et al., 63.5% with lifitegrast had OAE compared to 26% with placebo. The NNH was 5 in Holland et al., 3 in Sheppard et al., and 6 in Tauber et al.
Conclusions: Lifitegrast is slightly more effective than placebo in improving eye dryness, but not as safe based on the number of OAE. Lifitegrast can be considered a safe monotherapy for DED based on the efficacy of improving eye dryness and improbability of causing severe OAE.
Cole, Aubrey E., "Is Lifitegrast 5.0% Ophthalmic Solution Effective in Improving Eye Dryness and Safe, in Terms of Ocular Adverse Effects, in Adults 18 Years or Older with Dry Eye Disease?" (2019). PCOM Physician Assistant Studies Student Scholarship. 470.