Abstract

Purpose: To investigate whether the application of a novel product containing a mix of osmoprotectant soluble molecules can modify tear osmolarity, clinical signs and subjective symptoms in dry eye patients. Methods: Thirty patients (24 women, 6 men, median age 45.5 yrs) were enrolled. Inclusion criteria were: age ≥ 18 years, good general health, ocular discomfort symptoms for over three months, Ocular Surface Disease Index (OSDI) score ranging from 18 to 36, Schirmer test > 10 mm/5 min, Tear Film Break Up Time (TBUT) < 10 sec, corneal fluorescein staining ranging from 1 to 7 according to NEI level. Patients were administered three times daily for a two-month period with Isomar Eyes Plus, a hypotonic solution containing Hyaluronic Acid, Hypromellose and L-Carnitine, erythrol and betaine as osmoprotectant soluble molecules. Tear osmolarity (TearLab), Schirmer I Test, corneal and conjunctival vital stainings, conjunctival impression cytology with goblet cell (GCs) count, symptom intensity evaluation with VAS (Visual Analogue Scale) technique were performed and compared at endpoint versus baseline. Results: At endpoint versus baseline, respectively, variables significantly improved (Wilcoxon test, p always < 0.01). Data are expressed as median (min-max values) [CI 95%]). Tear osmolarity (mOsm/L): 290 (279-301) [286-298] versus 307 (293-315) [300-312]; OSDI (score): 16 (16-26) [16-19.4] versus 28 (18-36) [24-30]; VAS (score): 2.8 (1.5-3.5) [2.1-2.9] versus 5.9 (5.2-7.1) [5.8-6.1]; TFBUT (sec): 9.5 (8-12) [8.5-10.7] versus 7.1 (5.4-9) [6.5-7.8]; vital staining showed complete epithelial healing at endpoint in 48 out of 60 eyes; imprint cytology score: 1 (1-2) [1-1.2] versus 1.5 (1-2.5) [1-1.5]. GC density improved at endpoint (media ± SD: 182.6 ± 28.6 cells/mm2) as compared to baseline (142.5 ± 25.6 cells/mm2, p < 0.01). Tolerability was high, with no adverse events noted. Conclusions: A two-month treatment with Isomar eyes plus, containing L-Carnitine, Erythrol and Betaine as osmoprotectants, is able to reduce tear osmolarity, subjective symptoms of discomfort and ocular surface epithelial damage, associated to an increasing tear film stability.

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