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S.L. Watson, G. Geerling, J.K. G. Dart; Therapeutic Ocular Surface Medium: A Novel Therapy for Moderate to Severe Dry Eye . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2023.
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Purpose: To evaluate the clinical efficacy of a new novel therapy, Therapeutic Ocular Surface Medium (TOSM), for the treatment of moderate to severe dry eye. Methods: A non–comparative prospective pilot study enrolled 20 eyes of 10 patients, with moderate to severe dry eye, who had failed standard therapy. Patients with a Schirmer’s test ≤ 5mm at 5 minutes or tear break–up time ≤ 5 seconds were recruited from Corneal and External disease clinics at Moorfields Eye Hospital. One drop of TOSM was applied 8 times a day. Patients were assessed at enrolment and at one week, two weeks and four weeks. Objective signs and subjective symptoms of dry eye were graded at each visit and slit lamp photographs taken. In addition, conjunctival impression cytology was performed at enrolment and at the final visit. The Wilcoxon Signed Ranks test was used to analyse the outcome measures for the worse eye at baseline (the study eye), except for safety data, which was analysed using both eyes. Moorfields Eye Hospital Ethics committee approved the study and informed consent was obtained from all patients. Results: Significant improvement in rose Bengal staining from baseline to completion of the trial at 4 weeks was found in 7 of 10 patients in the study eye (p=0.0104). Subjective symptoms (dryness, FB sensation, discomfort, photophobia) improved in all 10 study eyes over this period (p=0.0049). Safety data analysis showed no significant change in the study or fellow eye for BCVA, IOP, or cataract. Conclusions: TOSM was effective in improving the subjective symptoms and objective signs of moderate to severe dry eye in patients who had failed standard therapy. TOSM is being evaluated in a randomized controlled trial to confirm its potential as a novel dry eye therapy.
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