A prospective, multicenter, noninterventional study of Optive Plus(®) in the treatment of patients with dry eye: the prolipid study.

OBJECTIVE

The aim was to evaluate the efficacy of Optive Plus(®), an artificial tear containing castor oil, in patients with dry eye, in a routine clinical setting.

METHODS

This was a prospective, noninterventional study of patients with dry eye who switched from a prior therapy or who were naïve to treatment (n=1,209). Patients were issued Optive Plus(®) artificial tears. Dry eye severity, tear break-up time (TBUT), Schirmer score, Ocular Surface Disease Index (OSDI) score, and patient assessment of symptoms were recorded at baseline and at the follow-up visit (4 weeks after starting Optive Plus(®)).

RESULTS

The cause of dry eye was determined to be aqueous deficiency, lipid deficiency, or a mixture of aqueous and lipid deficiency (in 19.5%, 20.1%, and 47.8%, respectively, of the total study population). The severity of dry eye decreased from baseline to the follow-up visit, showing a decrease of the more severe levels (2-4) and a concurrent increase in mild level (1) of the rating scale. Patients reported an improvement in dry eye symptoms over the duration of the study, specifically 74.2% (n=152), 85.4% (n=182), and 82.4% (n=417) of patients in the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. TBUT was measured in 475 patients. Baseline measurements for mean and standard deviation were 9.0±3.5, 7.1±3.6, and 6.6±3.0 seconds for the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. These increased to 10.5±3.5, 10.0±3.6, and 9.2±3.1 seconds at the final visit. Overall, 92.5% of all patients were satisfied with the use of Optive Plus(®), and 86% said they would purchase Optive Plus(®). Ten percent of patients reported adverse events, and 1.8% of all patients experienced treatment-related adverse events.

CONCLUSION

Optive Plus(®) was well tolerated and effective in reducing the signs and symptoms of all types of dry eye but is recommended for lipid-deficient dry eye patients.