Status:
COMPLETED
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 follow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00905450
Start Date
June 1 2009
End Date
May 1 2010
Last Update
September 22 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bausch & Lomb
Rochester, New York, United States, 14609