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

Bausch + Lomb

Status and phase

Completed

Phase 2

Conditions

Inflammation

Cataract

Treatments

Drug: Vehicle for BOL-303242-X

Drug: BOL-303242-X

Study type

Interventional

Funder types

Industry

Identifiers

NCT00905450

588

Details and patient eligibility

About

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.

Enrollment

415 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.