Evaluation of the First Metastable Lipid Emulsion on Symptomatic Dry Eye Patients

Abstract

Abstract: : Purpose: To evaluate the first metastable lipid emulsion on patients with signs and symptoms of dry eye syndrome. Methods: After informed consent, subjects (n=20) presenting consecutively with one or more of the following dry eye symptoms (dryness, grittiness or scratchiness; soreness or irritation; burning or watering) and signs of decreased tear–film break–up time (TFBUT) [<10 sec] and lipid layer thickness (LLT) [<90 nm] were selected. Frequency and severity of symptoms were tabulated and also quantified using a scored [SPEED (Korb, Herman, Greiner et al.: Eye & Contact Lens, 2005)] questionnaire; subjects with symptom scores >5 of 24 were enrolled. Statistical comparisons were computed from the numeric data using the paired t–test (2–tailed). TFBUT was determined using the DET^TM method (Korb, Greiner, Herman: Cornea 2001). LLT was evaluated at 0 (baseline), 1, 5, and 15 min using methods standard in our laboratory (Korb, Baron, Herman et al: Cornea 1994). Symptoms and signs were evaluated for each subject on day 1 and after using the metastable lipid emulsion (Soothe^TM, Alimera Sciences, Inc., Alpharetta, GA) a minimum of twice daily OU for a >1–month duration. Results: Regardless of the degree of dry eye symptoms, after one month, symptoms improved in all subjects (Frequency measures: dryness, grittiness or scratchiness, sig=0.000; soreness or irritation, sig=0.000; burning or watering, sig=0.012. Severity measures: dryness, grittiness or scratchiness, sig=0.000; soreness or irritation, sig=0.000; burning or watering, sig=0.058. Scored SPEED questionnaire, sig=0.000). There was a dramatic improvement in LLT over 0 min at the 1, 5, and 15 min time intervals at both the baseline visit and 1–month visit evaluations (Baseline visit: 0–1 min time interval, sig=0.000; 0–5, sig=0.000; 0–15, sig=0.000; 1–5, sig=0.024; 1–15, sig=0.012; 5–15, sig=0.350. 1–month visit: 0–1, sig=0.000; 0–5, sig=0.000; 0–15, sig=0.000; 1–5, sig=0.003; 1–15, sig=0.032; 5–15, sig=0.508). Conclusions: This new technology, the first metastable emulsion for the treatment of dry eye, proved highly effective in reducing dry eye symptoms after one month and in increasing the thickness of the tear film lipid layer within 1 minute of instillation. This is especially important when considering the correlation between tear film lipid layer thickness and dry eye syndromes (Isreb, Greiner, Korb et al: Eye 2003).

Keywords: cornea: tears/tear film/dry eye • lipids