Date of Award


Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant


Physician Assistant Studies

Department Chair

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.