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[求助]
Mapracorat这个药临床结果是成了还是没成，看不明白？
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Information Country USA Clinical Trials Local CT Number NCT01230125 Information Source Bausch & Lomb Incorporated Short Title Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery Long Title Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery Leader Bausch & Lomb Incorporated Phase Phase III Status Completed Enrollment 250 Country United States Study Type Interventional Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment Start Date November 2010 Completion Date August 2011 List of Ingredients Mapracorat ( Drug ) ; Vehicle ( Drug ) Summary The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Primary Outcome Resolution of anterior chamber (AC) cells: number of anterior chamber (AC) cells in study eyes measured on a scale of 0-4.Pain Scale: eye pain measured on a visual analog scale. Secondary Outcome Resolution of AC cells: number of anterior chamber (AC) cells in study eyes measured on a scale of 0-4.Pain Scale: eye pain measured on a visual analog scale.Resolution of anterior chamber (AC) flare: Scattering of a slit lamp light beam when directed into the AC (Tyndall effect). Tyndall effect measured on a scale of 0-4. Full Description Label: Mapracorat: -Type: Experimental-Description: Ophthalmic suspension 3%*Label: Vehicle: -Type: Placebo Comparator-Description: Vehicle of mapracorat ophthalmic suspension* nformation Country USA Clinical Trials Local CT Number NCT01298752 Information Source Bausch & Lomb Incorporated Short Title Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery Long Title The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery Leader Bausch & Lomb Incorporated Phase Phase III Status Terminated Stop Reason Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated. Enrollment 142 Country United States Study Type Interventional Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment Start Date February 2011 Completion Date November 2011 List of Ingredients Mapracorat ( Drug ) ; Vehicle ( Drug ) Summary The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Primary Outcome Inflammation: Study eyes with complete resolution of anterior chamber (AC) cells.Pain: study eyes with grade 0 pain, where 0=absence of pain Secondary Outcome Inflammation: study eyes with complete resolution of AC cells and flarePain: study eyes with grade 0 pain, where 0=absence of pain Full Description Label: Mapracorat: -Type: Experimental-Description: Mapracorat ophthalmic suspension*Label: Vehicle: -Type: Placebo Comparator-Description: Vehicle of mapracorat ophthalmic suspension* |
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