A review of the efficacy, safety and tolerability of Lacrycon® eye drops for the treatment of dry eye syndrome.

ABSTRACT

Lacrycon® is a preservative-free hypotonic artificial tear for the treatment of dry eye syndrome containing hyaluronic acid, carbomer, and glycerol. Lacrycon has been used for many years; this is the first comprehensive review of clinical efficacy and tolerability. Eight clinical studies (1992-2013) were reviewed. Comparators included phosphate-buffered saline (Phase I) and active controls (Phase II Lacrisol™; Phase III Gel-larmes™, Lacrisol, Hyalistil®, Vismed®, or the currently prescribed tear substitute). Administration schedules varied from 3 to 8 instillations per day for 7 to 84 days, and evaluation timepoints varied between studies. Pre-corneal retention of Lacrycon was 22% better than phosphate-buffered saline in terms of AUC (P=0.048). Patients' evaluation of efficacy was better for Lacrycon than Gel-larmes on Day 15 and 45 (P<0.05) and similar on Day 90 (P>0.05); there was no difference (P>0.05) versus Hyalistil (Day 30) or Vismed (Day 35 and 85). Functional tests were either in favor of Lacrycon (P<0.05) (fluorescein test [versus Gel-larmes/Lacrisol/Hyalistil], tear break-up time [TBUT] and rose Bengal test, Schirmer I test, and tear meniscus [versus Lacrisol]), or there was no difference between treatments (P>0.05) (fluorescein test [versus Vismed], TBUT and rose Bengal test [versus Gel-larmes], Schirmer I test [versus Gel-larmes/Lacrisol/Hyalistil/VisMed], tear meniscus [versus Lacrisol/Hyalistil], Oxford Grading Score, OSDI, van Bijsterveld score, and conjunctival hyperemia [versus Vismed]). Lacrycon was better tolerated than most comparators and had a similar safety profile to Vismed. No comparison showed favored the comparator over Lacrycon. These good efficacy, tolerability and safety data support the use of Lacrycon in dry eye syndrome.