Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery

This study has been terminated.
(Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01298752
First received: February 16, 2011
Last updated: November 22, 2013
Last verified: August 2013

February 16, 2011
November 22, 2013
February 2011
September 2011   (final data collection date for primary outcome measure)
  • Inflammation [ Time Frame: (Visit 5) Post-operative day 8 ] [ Designated as safety issue: No ]
    Study eyes with complete resolution of anterior chamber (AC) cells.
  • Pain [ Time Frame: (Visit 5) Post-operative day 8 ] [ Designated as safety issue: No ]
    study eyes with grade 0 pain, where 0=absence of pain
Same as current
Complete list of historical versions of study NCT01298752 on ClinicalTrials.gov Archive Site
  • Inflammation [ Time Frame: At each visit up to 4 weeks ] [ Designated as safety issue: No ]
    study eyes with complete resolution of AC cells and flare
  • Pain [ Time Frame: At each visit up to 4 weeks ] [ Designated as safety issue: No ]
    study eyes with grade 0 pain, where 0=absence of pain
Same as current
Not Provided
Not Provided
 
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery
The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • Pain
  • Cataract
  • Drug: Mapracorat
    Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
    Other Name: BOL-303242-X
  • Drug: Vehicle
    Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
  • Experimental: Mapracorat
    Mapracorat ophthalmic suspension
    Intervention: Drug: Mapracorat
  • Placebo Comparator: Vehicle
    Vehicle of mapracorat ophthalmic suspension
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
142
November 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are candidates for routine, uncomplicated cataract surgery.
  • Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

  • Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
  • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01298752
664
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Rabia Ozden, MD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP