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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cataract
Inflammation
Eye Diseases
Lens Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014