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

Completed · Phase 2

Conditions studied: Cataract, Inflammation

In brief

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.

Key facts

Study ID

NCT00905450

Run by

Bausch & Lomb Incorporated

People needed

415

Starts

2009-06-01

Expected to finish

2010-05-01

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb — Rochester, New York, United States

Full record on ClinicalTrials.gov

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