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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract Inflammation | Drug: BOL-303242-X Drug: Vehicle for BOL-303242-X | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: BOL-303242-X
BOL-303242-X (Mapracorat)
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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)
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Drug: Vehicle for BOL-303242-X
Medication instilled into the study eye, subjects randomized to various drug dose schedules. |
- Subjects with resolution of AC cells. [ Time Frame: Postoperative day 8 (Visit 5) ]
- Comfort [ Time Frame: Postoperative day 8 (Visit 5) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, New York | |
Bausch & Lomb | |
Rochester, New York, United States, 14609 |
Study Director: | Laura Trusso, MS | Bausch & Lomb Incorporated |
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:
Inflammation Cataract Pathologic Processes Lens Diseases Eye Diseases |