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Michael Watson, George W Ousler, Douglas Devries, Paul Karpecki, Joseph B Ciolino; Assessment of quality of life and symptom reduction in dry eye subjects using Retaine™ Ophthalmic Emulsion. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4483.
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The purpose of this study was to evaluate the rapid onset of efficacy of Retaine™ Ophthalmic Emulsion in reducing dry eye symptoms and improving the quality of life of subjects diagnosed with dry eye.
This single-center, open-label study consisted of two visits over approximately two weeks. Study participants dosed RetaineTM BID. Subjects were instructed to complete a symptomatology diary twice daily prior to drop instillation up through the morning of Visit 2. Ocular sign and symptom assessments, visual acuity procedures, and comfort assessments were conducted at both visits.
Forty two subjects with a mean age of 61.6 (range 26-89) years were enrolled in the study. Subjects demonstrated a statistically significant reduction in several patient reported symptoms after two weeks of dosing. From Visit 1 to Visit 2, subjects noted statistically significant reductions in dryness, grittiness, ocular discomfort, and all symptoms as measured by the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (0-5 Scale)(p<0.001, p=0.0217, p=0.0017, and p<0.001, respectively). Subjects reported improvements in their ability to watch TV at night, drive at night, and read at night, with statistically significant improvements in their ability to work with a computer at night (p=0.044). Mean drop comfort scores ranged from 1.29-1.81 on the Ora Calibra™ 0-10 Drop Comfort Scale.
For most eye care professionals, an artificial tear that demonstrates fast acting relief of symptoms and patient quality of life is the optimal choice. The outcomes of this study suggest that Retaine™ has the potential to significantly reduce the symptoms of dry eye after only two weeks of dosing. Achieving a statistically significant improvement in a quality of life measure (working at the computer at night) indicates how an efficacious tear substitute can benefit the patient on a global level. The rapid relief of symptoms suggests that RetaineTM may be used as a first line choice for all dry eye patients, including those that are concurrently dosing cyclosporine ophthalmic emulsion 0.05%.
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