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S.G. Pratt, G.W. Ousler, M. Schindelar, M.J. Chapin, M.B. Abelson; Evaluation of a Novel Dry Eye Oral Supplement for the Treatment of the Signs and Symptoms of Dry Eye in the Controlled Adverse Environment (CAE) Model . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2047.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the efficacy and safety of a novel Dry Eye Oral Supplement compared to a standard multivitamin in relieving the signs and symptoms of dry eye as induced by the controlled adverse environment (CAE). The use of the CAE allows for assessment before, during and following acute exacerbation of ocular signs and symptoms, allowing for a more comprehensive assessment of efficacy. This was a double–masked, randomized, controlled, parallel–group, 5–visit, single–center, CAE study evaluating signs and symptoms associated with dry eye. 24 dry eye patients entered a 3–week washout period. Following CAE screening, eligible patients were randomized to receive either the Dry Eye Oral Supplement or multi–vitamin placebo BID, in conjunction with the same standard artificial tear product TID for 10 weeks. Ophthalmic examinations and follow–up CAE challenges took place at weeks 3, 6 and 10. 23 patients completed the study. Patient reported symptom scores (0–4 on a standardized scale) during CAE exposure were compiled as follows:
Mean Total Discomfort during 90–Minute CAE Exposure
The active Dry Eye Nutritional Supplement was significantly more effective than placebo in this study for the treatment of the ocular symptoms associated with Dry Eye in the CAE. This controlled study showed that the novel Dry Eye Nutritional Supplement tested has potential for treating dry eye patient.
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