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Victor M Finnemore, Teresa Douglass, Abayomi B Ogundele, Donald R Korb; Effect of Systane® Family Products on Meibomian Gland Functionality in Patients With Lipid-Deficient Evaporative Dry Eye. Invest. Ophthalmol. Vis. Sci. 2014;55(13):44.
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To assess the effectiveness of using Systane® products (Systane Balance, Lid Wipes, and Vitamin Omega-3 Supplement) vs. the standard of care (warm compresses, with or without saline) in improving meibomian gland functionality in patients with lipid-deficient evaporative dry eye disease.
This was a single-center, open-label, investigator-masked, prospective study of patients aged ≥18 years with a clinical diagnosis of lipid-deficient evaporative dry eye and ≤6 meibomian glands yielding liquid secretion (MGYLS) at screening. Patients were randomly assigned to self-administer lid hygiene with Lid Wipes once daily, instill 1 drop of Systane Balance eye drops 4 times daily, and take 2 oral vitamin softgels once daily for 3 months, or to apply warm, wet microfiber compresses to both eyelids for 8 minutes once per day for 3 months. Meibomian gland functionality, the primary endpoint, was evaluated using a standardized diagnostic meibomian gland expressor to determine the number of MGYLS at baseline and after 1, 2, and 3 months of treatment. Best corrected visual acuity (BCVA) and adverse events (AEs) were evaluated as safety outcomes.
A total of 26 patients (n=52 eyes) were enrolled (women, n=21; men, n=5; mean age, 41.7 years). At baseline, the mean ± SD number of functioning glands for both eyes was 3.5±1.50 and 4.2±1.39 in the Systane and warm-compress groups, respectively. Meibomian gland functionality was increased from baseline in the Systane group at all follow-up visits and was significantly better in the Systane group compared with the warm-compress group at month 2 (6.4±2.45 vs. 3.5±1.90; P=0.0365) and month 3 (9.3±2.72 vs. 4.7±2.29; P=0.0061). One patient reported 2 AEs that were not related to treatment; no serious AEs were reported. BCVA was unchanged from baseline through month 3 in both treatment groups.
In patients with lipid-deficient evaporative dry eye, treatment with the Systane product family increased the number of MGYLS. Meibomian gland functionality was significantly better after 2 and 3 months of treatment with the Systane products when compared with the standard of care (warm compresses). No safety issues were reported with either treatment.
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