Real-World Evidence Highlights Underutilization of Diagnostic Testing in Inflammatory Dry Eye Disease
Overview
A large real-world study of 143,005 patients with dry eye disease (DED) initiating lifitegrast therapy revealed significant ocular and systemic comorbidities and demonstrated that diagnostic testing for DED is severely underutilized. The predominantly female cohort showed broad geographic and insurance representation, providing generalizable insights into current clinical practice patterns.
Background
Dry eye disease (DED) is a common ocular condition often associated with systemic and ocular comorbidities. Lifitegrast ophthalmic solution 5% is an approved treatment for inflammatory DED. Despite available diagnostic tests such as tear breakup time and Schirmer testing, their use in routine clinical practice remains unclear. Understanding real-world patient characteristics, diagnostic approaches, and treatment patterns is essential to optimize DED management.
Data Highlights
| Characteristic | Value |
|---|---|
| Number of patients | 143,005 |
| Mean age (years) | 61 ± 14 |
| Female patients | 114,563 (80%) |
| Race distribution | White 55%, Black 5%, Asian 5%, Other 9%, Unknown 25% |
| Ethnicity | Not Hispanic/Latino 60%, Hispanic/Latino 7% |
| Common ocular comorbidity | Cataract |
| Nonocular comorbidities | Hyperlipidemia 45%, Hypertension 43%, Type 2 diabetes 18%, Sjögren syndrome/rheumatoid arthritis 11% |
| Prior dry eye therapy | 10% used other therapies |
| Prescriber specialties | Optometrists 44%, Cataract/anterior segment 19%, Cornea/comprehensive ophthalmologists 14%, Others 23% |
| Tear breakup time <5 seconds | 3.9% |
| Abnormal Schirmer test | <2% |
| Schirmer test unknown | 98% |
Key Findings
- The study cohort was predominantly female (80%) with a mean age of 61 years, reflecting a typical DED population.
- Cataract was the most common ocular comorbidity; systemic conditions such as hyperlipidemia and hypertension were prevalent.
- Only 10% of patients had used other dry eye therapies prior to lifitegrast initiation, indicating a large untreated population.
- Diagnostic testing for DED was markedly underutilized: less than 4% had tear breakup time under 5 seconds, and less than 2% had abnormal Schirmer tests, with 98% unknown.
- Therapeutic optometrists accounted for 44% of prescribers, with broad involvement from ophthalmic subspecialties.
- The findings highlight significant practice gaps in DED diagnosis and management outside clinical trials.
Clinical Implications
Clinicians should be aware of the high prevalence of ocular and systemic comorbidities in patients with DED and consider comprehensive evaluation. The underuse of diagnostic tests such as tear breakup time and Schirmer testing suggests a need to incorporate standardized diagnostic algorithms into routine practice to better target therapy. Early identification and treatment initiation may improve patient outcomes in this largely untreated population.
Conclusion
This large real-world study underscores significant practice gaps in the diagnosis and management of inflammatory dry eye disease, emphasizing the need for improved diagnostic testing and earlier therapeutic intervention to optimize patient care.
References
- Mercado CL et al. 2026 ASCRS Annual Meeting -- Real-World Evidence for Inflammatory Dry Eye Disease
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