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Vincent Baeyens, Christopher Baudouin, J.Anthony J. Bron, Vismed Study Group; Effectiveness Of Vismed® (0.18% Sodium Hyaluronate, Hypotonic Ophthalmic Solution) In The Treatment Of The Signs And Symptoms Of Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3836.
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To compare the efficacy and safety of hypotonic 0.18% sodium hyaluronate (Vismed®) versus saline and 0.3% carbomer in patients with bilateral moderate dry eye syndrome.
This was a randomised, double-blind, controlled, parallel-group, 3-arm, 3 months, phase III trial in 304 patients. The primary efficacy criterion was the symptom frequency at D28 . Secondary efficacy criteria were symptoms intensity, impact of symptoms on daily life activities, slit lamp examination, staining with lissamine green and fluorescein, Schirmer I, tear film BUT, visual acuity, number of instillations and global efficacy evaluation. Comfort of the eye drops, visual acuity slit lamp examination and adverse events reporting were used for safety evaluation.
At D28, there was a statistically significant (p=0.0376) superiority of Vismed® over saline in change from baseline for the symptom frequency, and the non inferiority at 0.8 points of Vismed® relatively to carbomer was demonstrated. Results for corneal staining with fluorescein showed a statistically significant superiority of Vismed® versus saline at D28 (p=0.0074) and D56 (p=0.0360). Vismed® caused a greater increase in mean values of tear film BUT compared with saline and carbomer, observed at all the visits, and statistically significant (p=0.039) at D56. The average number of instillations per day was lower with Vismed® compared with carbomer and saline; ie 3.06, 3.13 and 3.28 over the 3 months, respectively. Less patients using Vismed® reported blurred vision than those using carbomer (eg 48.0% and 59.1% at D28, respectively). The other efficacy parameters evidenced the beneficial effect of Vismed® in signs and symptoms of dry eye. Vismed® had an excellent safety profile over 84 days.
Vismed® was significantly more efficient than saline in reducing symptom frequency. In addition, the present study highlighted the better comfort of Vismed® relatively to carbomer, as well as a lower number of instillations required. The accomplishment in these two criteria, which are fundamental features of eyedrops for patient well-being, turns out to be an asset for Vismed®. In this trial, success was achieved in both, the subjective frequency of symptoms and the objective sign of staining with fluorescein. Vismed® was well tolerated and resulted in low incidence of adverse events.
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