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B. H. Koffler, LAC-07-01 Study Group; Lacrisert® (hydroxypropyl cellulose ophthalmic insert) Significantly Improves Symptoms of Dry Eye Syndrome and Patient Quality of Life. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4660.
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Approximately 1 in 3 patients seeking eye care have symptoms of Dry Eye Syndrome (DES). Nearly 5 million Americans aged 50 years and older are affected by DES, with a predicted increase in occurrence over the coming decades accompanying the growing older population. Symptoms of DES, particularly those of moderate to severe disease, are subjective, and do not necessarily correlate with clinical signs; the converse is also true. Additional treatment options, especially those without inflammatory preservatives, are absolutely necessary for the treatment of patients with moderate to severe DES. A multicenter, 2 visit, open label, 4-week study was conducted to determine the acceptability and ease of use of LACRISERT (hydroxypropyl cellulose ophthalmic insert) in adult patients with a history of DES. It was hypothesized that patients would experience improvements in their overall quality of life with only negligible negative effects.
At visit 1, patients (N=520) were given a general dry eye evaluation (investigator’s discretion), screened by slit-lamp biomicroscopy and best corrected visual acuity, and were required to fill out a questionnaire to complete the ocular surface disease index (OSDI), a validated measure of quality of life. Patients were trained on the proper insertion and use of LACRISERT. Patients were contacted by telephone on Day 3 of the study for follow up and reinstruction. At visit 2 (Week 4), patients were given a clinical evaluation and required to complete a second evaluation. Answers provided on questionnaires (scored as numerical scales) were used to determine changes in patient reported outcomes such as symptoms and quality of life. Adverse events were monitored throughout the study and reviewed by investigators.
Mean OSDI total scores significantly improved by more than 25% (from 41.8±22.38 at visit 1 to 32.9±21.97, P≤0.0215). Treatment with LACRISERT resulted in significant improvement in mean occurrence of discomfort in heated areas (P<0.0001) and significant improvements when performing housework (P=0.0018). Patients reported significant reductions in mean severity of DES symptoms (P<0.0001). The most commonly reported adverse event leading to discontinuation was blurred vision, observed in 8.7% of patients (n=45).
Use of LACRISERT resulted in significant improvements in DES symptoms, activities of daily living, and patient quality of life, with a >25% improvement in mean OSDI total scores.
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