Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00905450
First received: May 19, 2009
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.


Condition Intervention Phase
Cataract
Inflammation
Drug: BOL-303242-X
Drug: Vehicle for BOL-303242-X
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Subjects with resolution of AC cells. [ Time Frame: Postoperative day 8 (Visit 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comfort [ Time Frame: Postoperative day 8 (Visit 5) ] [ Designated as safety issue: No ]

Enrollment: 415
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOL-303242-X
BOL-303242-X (Mapracorat)
Drug: BOL-303242-X
Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.
Other Name: Mapracorat
Placebo Comparator: Vehicle
Vehicle for BOL-303242-X (Mapracorat)
Drug: Vehicle for BOL-303242-X
Medication instilled into the study eye, subjects randomized to various drug dose schedules.

  Eligibility

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

Inclusion Criteria:

  • Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
  • Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
  • Subjects who are candidates for cataract surgery.
  • Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
  • Subjects must be able and willing to comply with all treatment and follow- up procedures.

Exclusion Criteria:

  • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
  • Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905450

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Laura Trusso, MS Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00905450     History of Changes
Other Study ID Numbers: 588
Study First Received: May 19, 2009
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Surgery

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

ClinicalTrials.gov processed this record on April 14, 2014