1. Clinical trials of therapeutic ocular surface medium for moderate to severe dry eye.
- Author
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Watson SL, Daniels JT, Geerling G, and Dart JK
- Subjects
- Adult, Aged, Blepharitis drug therapy, Blepharitis pathology, Cell Survival drug effects, Conjunctiva pathology, Double-Blind Method, Dry Eye Syndromes pathology, Dry Eye Syndromes physiopathology, Female, Fluorescent Dyes, Humans, Male, Middle Aged, Pilot Projects, Prospective Studies, Rose Bengal, Severity of Illness Index, Staining and Labeling, Young Adult, Dry Eye Syndromes drug therapy, Ophthalmic Solutions therapeutic use
- Abstract
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.
- Published
- 2010
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