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

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ClinicalTrials.gov Identifier: NCT00905450
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Inflammation Drug: BOL-303242-X Drug: Vehicle for BOL-303242-X Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Subjects with resolution of AC cells. [ Time Frame: Postoperative day 8 (Visit 5) ]

Secondary Outcome Measures :
  1. Comfort [ Time Frame: Postoperative day 8 (Visit 5) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT00905450


Locations
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United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Laura Trusso, MS Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00905450     History of Changes
Other Study ID Numbers: 588
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2013

Keywords provided by Bausch & Lomb Incorporated:
Surgery

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