PURPOSE: To evaluate Artelac Rebalance® eyedrops' efficacy in symptoms reduction, ocular surface parameters recovery, and tolerability in the treatment of mild to moderate dry eye. METHODS: Fifteen patients were enrolled. Inclusion criteria were Ocular Surface Disease Index (OSDI) score >16, tear film break-up time (TFBUT) <10 seconds, Schirmer test I >10 mm/5 min, and mild ocular surface damage (Oxford grading) ≤3. Artelac Rebalance® eyedrops were administered 3 times daily for 2 months. Patients were evaluated at enrollment, after 2 days of washout (baseline), and after 1 and 2 months of treatment. Parameters for ocular discomfort (OSDI score), tear film quality (Schirmer test I, TFBUT, tear osmolarity), ocular surface damage (fluorescein staining, conjunctival imprint cytology), and inflammation (scraping cytology and exuded serum albumin) were measured. Tolerability and satisfaction were assessed by validated questionnaires. RESULTS: At endpoint versus baseline, all variables showed a statistically significant improvement (paired Student t test, p<0.01 for all parameters) as follows: OSDI score (21.9 ± 10.6 vs 35.8 ± 12.2), TFBUT (6.5 ± 1.1 s vs 5.2 ± 2.3 s), Oxford grading of corneal and conjunctival damage (0.56 ± 0.50 vs 1.16 ± 0.37), tear osmolarity (294.6 ± 2.1 mOsm/L vs 303.1 ± 4.6 mOsm/L), conjunctival goblet cell density/mm2 (140.8 ± 43.3 cells/mm2 vs 115.1 ± 15.8 cells/mm2), scraping cytology score (2.9 ± 1.0 vs 4.2 ± 1.3), and percentage of serum albumin in tears (9.2% ± 4.8% vs 24.1% ± 10.8%). Tolerability and satisfaction were scored high, with no adverse events reported. CONCLUSIONS: Application of Artelac Rebalance® eyedrops for 2 months in mild to moderate dry eye resulted in a reduction of ocular inflammation parameters, ocular surface damage, and subjective discomfort symptoms, with a parallel improvement in tear film quality (measured by TFBUT and osmolarity).
PURPOSE: To evaluate Artelac Rebalance® eyedrops' efficacy in symptoms reduction, ocular surface parameters recovery, and tolerability in the treatment of mild to moderate dry eye. METHODS: Fifteen patients were enrolled. Inclusion criteria were Ocular Surface Disease Index (OSDI) score >16, tear film break-up time (TFBUT) <10 seconds, Schirmer test I >10 mm/5 min, and mild ocular surface damage (Oxford grading) ≤3. Artelac Rebalance® eyedrops were administered 3 times daily for 2 months. Patients were evaluated at enrollment, after 2 days of washout (baseline), and after 1 and 2 months of treatment. Parameters for ocular discomfort (OSDI score), tear film quality (Schirmer test I, TFBUT, tear osmolarity), ocular surface damage (fluorescein staining, conjunctival imprint cytology), and inflammation (scraping cytology and exuded serum albumin) were measured. Tolerability and satisfaction were assessed by validated questionnaires. RESULTS: At endpoint versus baseline, all variables showed a statistically significant improvement (paired Student t test, p<0.01 for all parameters) as follows: OSDI score (21.9 ± 10.6 vs 35.8 ± 12.2), TFBUT (6.5 ± 1.1 s vs 5.2 ± 2.3 s), Oxford grading of corneal and conjunctival damage (0.56 ± 0.50 vs 1.16 ± 0.37), tear osmolarity (294.6 ± 2.1 mOsm/L vs 303.1 ± 4.6 mOsm/L), conjunctival goblet cell density/mm2 (140.8 ± 43.3 cells/mm2 vs 115.1 ± 15.8 cells/mm2), scraping cytology score (2.9 ± 1.0 vs 4.2 ± 1.3), and percentage of serum albumin in tears (9.2% ± 4.8% vs 24.1% ± 10.8%). Tolerability and satisfaction were scored high, with no adverse events reported. CONCLUSIONS: Application of Artelac Rebalance® eyedrops for 2 months in mild to moderate dry eye resulted in a reduction of ocular inflammation parameters, ocular surface damage, and subjective discomfort symptoms, with a parallel improvement in tear film quality (measured by TFBUT and osmolarity).
Authors: Philipp Steven; Albert J Augustin; Gerd Geerling; Thomas Kaercher; Florian Kretz; Kathleen Kunert; Johannes Menzel-Severing; Norbert Schrage; Wolfgang Schrems; Sonja Krösser; Michael Beckert; Elisabeth M Messmer Journal: J Ocul Pharmacol Ther Date: 2017-09-18 Impact factor: 2.671