Comment on efficacy, safety, and tolerability of Lifitegrast 5% eye drops: A randomized, double-blind, active-controlled trial in Indian patients with dry eye disease

Dear Editor, We read the article titled “Efficacy, safety, and tolerability of Lifitegrast 5% eye drops: A randomized, double-blind, active-controlled trial in Indian patients with dry eye disease” published in August 2024.[1] The study provides an important contribution to the field of dry eye disease (DED) by comparing Lifitegrast and carboxymethylcellulose (CMC), an active control widely used in clinical practice. The detailed analysis of both subjective and objective measures of DED is commendable; in addition, by examining multiple parameters, the study covers almost all necessary aspects of Lifitegrast. The study being double-blinded shows more accuracy. The inclusion of early follow-up visits provides valuable insights into the rapid onset of symptom relief. However, Lifitegrast, an anti-inflammatory drug, was compared with CMC (artificial tear substitute), which provides symptomatic relief and no anti-inflammatory effects. Comparison with another anti-inflammatory drug such as cyclosporin or corticosteroids would have provided a more comprehensive evaluation of Lifitegrast’s efficacy in treating the underlying inflammation of DED compared to existing anti-inflammatory options. Even though the study reports adverse events such as eye pruritus, redness, and lid edema, it does not clearly specify whether these events were directly linked to the drug usage or were due to the progression of DED itself as DED can worsen over time. Similarly, the study did not classify the participants based on the severity of DED as mild, moderate, or severe, nor did it differentiate between the two main subtypes of DED—aqueous-deficient dry eye and evaporative dry eye—as they have distinct underlying mechanisms and respond differently to treatments. Without the classification, the results may not fully capture the variability in patient responses that could be caused due to differences in DED subtype or severity.[2] Detailed classification of DED in terms of both severity and type would allow a clearer understanding of which subsets of patients are most likely to benefit from Lifitegrast and could lead to more targeted treatment approaches. Although the study demonstrates statistically significant improvements in almost all parameters for Lifitegrast compared with CMC, it remains unclear whether these improvements are clinically significant. It would be beneficial if the study provided more insights into whether the changes observed in subjective symptoms and objective measures are clinically significant. While the study provides valuable insights into Lifitegrast’s role in dry eye disease, addressing these concerns will enhance the applicability of Lifitegrast and pave the way for guiding further clinical research. Financial support and sponsorship: Nil. Conflicts of interest: There are no conflicts of interest.