Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT01298752|
Recruitment Status : Terminated (Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.)
First Posted : February 18, 2011
Last Update Posted : December 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Pain Cataract||Drug: Mapracorat Drug: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2011|
Mapracorat ophthalmic suspension
Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
Other Name: BOL-303242-X
Placebo Comparator: Vehicle
Vehicle of mapracorat ophthalmic suspension
Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
- Inflammation [ Time Frame: (Visit 5) Post-operative day 8 ]Study eyes with complete resolution of anterior chamber (AC) cells.
- Pain [ Time Frame: (Visit 5) Post-operative day 8 ]study eyes with grade 0 pain, where 0=absence of pain
- Inflammation [ Time Frame: At each visit up to 4 weeks ]study eyes with complete resolution of AC cells and flare
- Pain [ Time Frame: At each visit up to 4 weeks ]study eyes with grade 0 pain, where 0=absence of pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298752
|United States, New York|
|Bausch & Lomb Incorporated|
|Rochester, New York, United States, 14609|
|Study Director:||Rabia Ozden, MD||Bausch & Lomb Incorporated|