title: Discomfort symptoms reduction and ocular surface parameters recovery with Artelac Rebalance treatment in mild-moderate dry eye.
abstract: OBJECTIVE
  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.affiliation: Ophthalmology Unit, Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Teaching Hospital, Bologna, Italy. piera.versura@unibo.it
authors.forename: Piera
authors.initials: P
authors.lastname: Versura
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Profazio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giannaccare
authors.forename: Michela
authors.initials: M
authors.lastname: Fresina
authors.forename: Emilio C
authors.initials: EC
authors.lastname: Campos
mesh_terms: D003228:Conjunctiva / Q000378:metabolism / Q000473:pathology; D003315:Cornea / Q000473:pathology; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D019793:Fluorescein / Q000378:metabolism; D020397:Goblet Cells / Q000166:cytology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D013666:Tears / Q000737:chemistry / Q000502:physiology
chemical_list: D009883:Ophthalmic Solutions; D019793:Fluorescein