Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00905450
First received: May 19, 2009
Last updated: May 30, 2013
Last verified: May 2013
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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: | 380 |
| 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 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: | May 30, 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 June 17, 2013