Evaluation of a preservative-free, cross-linked sodium hyaluronate-based solution, Lacri +®, in dogs with dry eye: a pilot trial.

Abstract

Background: The purpose of this pilot trial was to evaluate the efficacy and benefits of a preservative-free cross-linked sodium hyaluronate solution (Lacri +^®, MP Labo, France) in 19 privately-owned dogs with dry eye. The animals were administered 2 drops of the tested product in each affected eye, twice a day (BID) for 30 days. Improvement in the global ocular clinical score (sum of the individual scores for conjunctivitis, ocular discharge, eye irritation, and corneal opacity/pigmentation/vascularization, each rated from 0 to 3) was defined as the primary outcome. Besides an improvement in each individual ocular score, tear film quality (Tear Break Up Time, TBUT), dogs' and owners' quality of life (QoL), as well as an increase in tear production (Schirmer Tear Test-1, STT1), were considered secondary outcomes. These criteria were assessed on D0, D0 + 15 days, and D0 + 30 days. Finally, a qualitative evaluation of clinical improvement was requested from the owners on D0 + 2, + 15 & + 30 days and from the investigators during the follow-up.

Results: The global clinical ocular score as well as the individual conjunctival and irritation scores improved significantly (p < 0.0001) during the pilot trial. The average reduction of the global score reached 30% on D0 + 15 days and 55% on D0 + 30 days compared to D0. Ocular discharge was significantly lower (p = 0.0002) on D0 + 30 days compared to baseline; however corneal opacity did not show any significant changes from D0 to the end of the follow-up period. The quantitative tear production was increased at D + 30 (p < 0.0001), with a significant improvement as soon as 2 weeks in, with around 30% and 60% of dogs presenting an STT1 value above 10 on D0 + 15 days and on D0 + 30 days, respectively. The QoL score was significantly improved compared to D0 at all time points (p < 0.0001). After 2 days of treatment, 39% of the owners rated the efficacy as "good". The efficacy of the tested product was considered "Good" or "Very Good" by the investigators in 78% and 93% of the cases, on D0 + 15 days and D0 + 30 days, respectively. The tolerance of this preservative-free formulation was good, with only rare and transient minor local reactions, realated to administration rather than the product itself.