Cornea. 2010 Aug 5. [Epub ahead of print]
Watson SL, Daniels JT, Geerling G, Dart JK.
From the *Cornea and External Diseases, Moorfields Eye Hospital, London, United Kingdom; daggerOcular Repair and Regeneration Biology Unit, Department of Pathology, Institute of Ophthalmology, University College London, London, United Kingdom; double daggerDepartment of Ophthalmology, University of Würzburg, Würzburg, Germany; and section signDepartment of Pathology, Institute of Ophthalmology, University College London, London, United Kingdom.
PURPOSE: To investigate therapeutic ocular surface medium (TOSM), a potential physiological tear replacement therapy, for moderate to severe dry eye.
METHODS: Forty-six patients with symptoms of moderate to severe dry eye despite maximal standard therapy were enrolled in a prospective pilot study of TOSM over 1 month (n = 10) and a randomized, double-masked, controlled trial of TOSM versus saline (placebo) over 2 months (n = 36). The primary outcome measure was conjunctival rose bengal staining.
RESULTS: An improvement in conjunctival rose bengal staining by >/=3 points occurred in 7 of 10 patients receiving TOSM in the pilot study (P = 0.017) and in 8 of 18 patients (44%) in the randomized trial (P = 0.982). In the pilot study, subjective dry eye symptoms significantly improved (P = 0.005). TOSM significantly improved the blepharitis score (P = 0.002) and conjunctival impression cytology (P = 0.028) in the randomized controlled trial. There were no serious or irreversible side effects with TOSM.
CONCLUSIONS: TOSM is a physiological tear replacement for dry eye that, unlike autologous serum, can be easily manufactured, could be widely available, and may also be beneficial for blepharitis.
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