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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: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Inflammation
Pain
Cataract
 Drug: Mapracorat
Drug: Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 175
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mapracorat
Mapracorat ophthalmic suspension
 Drug: Mapracorat
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
 Drug: Vehicle
Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298752

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Rabia Ozden, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01298752     History of Changes
Other Study ID Numbers: 664
Study First Received: February 16, 2011
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013