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A Clinical Phase II Study to Assess Efficacy,Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease

Institution:	1. Eye Research Foundation, Newport Beach, California;2. Andover Eye Associates, Andover, Massachusetts;3. MedRACS Clinical Research, LLC, Quincy, Massachusetts;4. Central Maine Eye Care, Lewiston, Maine;5. Massachusetts Eye and Ear Infirmary / Harvard Medical School, Boston, Massachusetts;6. BAST Modelling & Simulation Consultancy Service, Heidelberg, Germany;7. Clinical and Regulatory Affairs Consultancy Services (CaRACS), Berlin, Germany;8. Ora Inc, Andover, Massachusetts;9. Department of Ophthalmology, Medical Faculty, University of Cologne, Cologne, Germany;10. Novaliq GmbH, Heidelberg, Germany

Abstract:

Keywords:	AE"} {"#name":"keyword" "$":{"id":"kwrd0015"} "$$":[{"#name":"text" "_":"adverse event CFS"} {"#name":"keyword" "$":{"id":"kwrd0025"} "$$":[{"#name":"text" "_":"corneal fluorescein staining CI"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"confidence interval CsA"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"cyclosporine A DED"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"dry eye disease MedDRA"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"Medical Dictionary for Regulatory Activities NEI"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"National Eye Institute OSDI"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"Ocular Surface Disease Index QoL"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"quality of life TEAE"} {"#name":"keyword" "$":{"id":"kwrd0105"} "$$":[{"#name":"text" "_":"treatment-emergent adverse event VAS"} {"#name":"keyword" "$":{"id":"kwrd0115"} "$$":[{"#name":"text" "_":"visual analog scale
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