title: Effects of Systane(®) Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye.
abstract: OBJECTIVE
  To evaluate the ability of Systane(®) Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up time (NITFBUT) over baseline compared with a saline (SAL) control in patients with lipid-deficient dry eye (DE).
  
  
  METHODS
  Patients aged ≥18 years with DE and evidence of meibomian gland dysfunction (ie, abnormal gland expression and missing meibomian glands) were included in this randomized, parallel-group, controlled, investigator-masked comparison study. Patients were randomized to SYSB or SAL four times daily for 4 weeks. The primary efficacy variable was mean change in NITFBUT from baseline at week 4. Ocular surface staining, goblet cell density, and meibomian gland expression were also assessed. Safety assessments included adverse events (AEs), best-corrected visual acuity, and ocular signs.
  
  
  RESULTS
  A total of 49 patients received study treatments (SYSB, n=25; SAL, n=24). Most patients were women (67.4%) and Caucasian (63.3%); mean ± standard deviation (SD) age was 44±19 years. DE characteristics at baseline were similar between groups. After 4 weeks of treatment, the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB (2.83±0.74 seconds) compared with SAL (0.66±0.55 seconds; P<0.001, t-test). Improvements in conjunctival and corneal staining, percentage of patients with increased goblet cell density, and meibomian gland expression were also observed with 4 weeks of SYSB over SAL. No AEs were reported for either treatment group; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline.
  
  
  CONCLUSIONS
  SYSB restored tear film stability, improved ocular surface healing, and improved meibomian gland functionality after 4 weeks of use in patients with lipid-deficient DE. No AEs were reported with either SYSB or SAL.
authors.affiliation: Universidad de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Alejandro J
authors.initials: AJ
authors.lastname: Aguilar
authors.affiliation: Universidad de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Maria I
authors.initials: MI
authors.lastname: Marquez
authors.affiliation: Universidad de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Paula A
authors.initials: PA
authors.lastname: Albera
authors.affiliation: Universidad de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Tredicce
authors.affiliation: Universidad de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Berra
keywords: artificial tears; conjunctival staining; corneal staining; goblet cells