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V. Baeyens, C. Baudouin, F. Dorsey, French Vismed Study Group; Efficacy and safety of sodium hyaluronate 0.18% Vs. sodium chloride 0.9% in patients with bilateral moderate dry eye . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3906.
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Purpose: To compare the efficacy and safety of hypotonic sodium hyaluronate (SH) 0.18% (Vismed®) and sodium chloride (SC) 0.9% in patients diagnosed with bilateral moderate dry–eye syndrome. Methods: Randomized (1:1), double–masked, parallel–group, controlled, multicentric (18 centres in France) study in which 150 patients received hypotonic SH 0.18% or SC 0.9% (3 to 8 instillations per day) for 1 month following a washout period of 2 weeks with a commercial preservative–free artificial tear. Efficacy variables were the composite index of global symptom intensity on VAS and symptoms frequency score, lissamine green and fluorescein staining scores, tear volume, tear film BUT and number of instillations. Safety was assessed by general ophthalmic examination, visual acuity, slit lamp examination and adverse event reporting. Results: No adverse reaction related to the use of SH or SC was reported by any patient or observed by the investigator. Mean (SD) number of instillations was 3.7 (1.4) in the SH group and 3.8 (1.1) in the SC group (NS). At M1, SH produced a significantly (p=0.0222) better reduction in the composite index of symptoms intensity and frequency compared to SC (62% and 54%, respectively). There was a significant difference between groups in favour of SH for lissamine green staining score at both, D7 (p=0.0013) and M1 (p=0.0007) visits. Reduction in fluorescein staining score also tended to be better in the SH group than in the SC group at D7 (p=0.0546) and M1 (p=0.0279). Repercussion of symptoms on daily life activities was significantly lower in the SH group compared to the SC group at D7 (p=0.0235) and M1 (p=0.0053). At M1, comfort of the eye drop was significantly (p=0.0158) better in patients treated with SH than in patients who received SC. Tear volume and tear film BUT did not show any difference between the 2 groups. Conclusions: SH was significantly more efficient than SC in reducing both, the subjective symptoms variables (intensity and frequency of symptoms, repercussion on daily life activities, comfort) and clinical signs (lissamine green). Both products were well tolerated.
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