A Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Clinical Study to Examine the Safety and Efficacy of T-Clair SPHP700-3 in the Management of Mild to Moderate Dry Eye in Adults.
Cornea. 2010 Nov 17. [Epub ahead of print]
Villani E, Laganovska G, Viola F, Pirondini C, Baumane K, Radecka L, Ratiglia R.
From the *UO Oculistica, Dipartimento di Neuroscienze e Organi di Senso, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Universitá degli Studi di Milano, Milan, Italy; and †Department of Ophthalmology, Stradins University Hospital, Riga, Latvia.
PURPOSE: To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults.
METHODS: Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment.
RESULTS: No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment.
CONCLUSIONS: SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.
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