Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye

Abstract

PurposeTo 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).Patients and methodsPatients 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.ResultsA 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.ConclusionSYSB 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.

Over the counter (OTC) artificial tear drops for dry eye syndrome

“…Baseline values were not equivalent in seven (16%) trials (Aguilar 2014; Benelli 2010; Bron 1998a; Bruix 2006; Dumbleton 2009; Sullivan 1997; Waduthantri 2012). …”

“…Table 3 presents a summary of interventions and comparisons. All but six trials (Aguilar 2014; Benelli 2010; Garcia-Lazaro 2011; Huth 2008; Khanal 2007; Simmons 2004a) assessed subjective dry eye symptoms. Objective physical examination and diagnostic tests, including Schirmer’s test, TBUT, ocular staining, and osmolarity, were performed in all trials except Simmons 2004a.…”

“…Twenty trials were reported as being double-masked (Baeyens 2012; Bron 1998a; Christensen 2009; Cohen 2014; Johnson 2008; Nelson 1988; Tomlinson 2013), single-masked (Foley-Nolan 1995), masked (Simmons 2007), masked-observer (Lee 2011) or investigator-masked trials (Aguilar 2014; Benelli 2010; Brodwall 1997; Bron 1998b; Donshik 1998 Trial 2; Donshik 1998 Trial 3; Khanal 2007; Kislan 2008; Simmons 2004a; Xiao 2008), but insufficient details were provided as to how masking was performed. Iester 2000 did not report masking.…”

“…Only six (14%) trials (Aguilar 2014; Baeyens 2012; Christensen 2009; Simmons 2015a; Simmons 2015b; Waduthantri 2012) had published protocols or registered their trials prior to publishing the results of their trials. Of these six trials, all prespecified outcomes were reported in Aguilar 2014,; Simmons 2015a, Simmons 2015b (low risk); secondary outcomes were not presented in the protocol in Baeyens 2012 (unclear risk); results from Christensen 2009 were only reported in a conference abstract (unclear risk); and not all pre-specified outcomes in the protocol were reported in the final paper in Waduthantri 2012 (high risk).…”

“…Of these six trials, all prespecified outcomes were reported in Aguilar 2014,; Simmons 2015a, Simmons 2015b (low risk); secondary outcomes were not presented in the protocol in Baeyens 2012 (unclear risk); results from Christensen 2009 were only reported in a conference abstract (unclear risk); and not all pre-specified outcomes in the protocol were reported in the final paper in Waduthantri 2012 (high risk). We rated 28 (65%) trials as unclear risk of bias due to insufficient information to permit judgment.…”