Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye.
OBJECTIVE
The aim of this prospective, randomized, clinical, single-center study was to compare the safety and efficacy of 2 ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD(®)) eye drops versus preservative-free Tamarindus indica seed polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO(®)) eye drops.


METHODS
Fifty-six eyes of 28 patients with moderate keratoconjunctivitis sicca (DEWS severity level 2) were enrolled in the trial. Patients were randomized for 2 treatment groups (SYSTANE UD eye drops vs. VISINE INTENSIV 1% EDO eye drops). The eye drops in both groups were applied 5 times per day for 3 months. Statistical analyses were performed using Statistica™ software (Mann-Whitney U-test and Wilcoxon test). P-Values<0.05 were considered significant.


RESULTS
After 3 months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the Ocular Surface Disease Index (OSDI) questionnaire score. Patients treated with HP-Guar and TSP showed improvements in tear film stability measured by tear break-up time (TBUT), which are statistically significant in the HP-Guar group (P=0.02).


CONCLUSIONS
The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of preservative-free HP-Guar and TSP lubricant eye drops. Both artificial tear formulations produce amelioration in tear film stability improving eye conditions and patient quality of life. HP-Guar seems to be slightly more effective in improving ocular surface protection by decreasing tear film evaporation.
Department of Ophthalmology, University of Erlangen-Nuremberg, Erlangen, Germany. christina.jacobi@uk-erlangen.de
Christina
C
Jacobi
Friedrich E
FE
Kruse
Claus
C
Cursiefen
D060433:Administration, Ophthalmic; D000328:Adult; D005260:Female; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D011788:Quality of Life; D012639:Seeds; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D029861:Tamarindus / Q000737:chemistry*; D013666:Tears / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome
D009883:Ophthalmic Solutions; D011134:Polysaccharides; C519976:hydroxypropyl guar