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

NCT ID: NCT00905450

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

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 following cataract surgery.

Conditions

Cataract; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BOL-303242-X

BOL-303242-X (Mapracorat)

Group Type: EXPERIMENTAL

BOL-303242-X

Intervention Type: DRUG

Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.

Vehicle

Vehicle for BOL-303242-X (Mapracorat)

Group Type: PLACEBO_COMPARATOR

Vehicle for BOL-303242-X

Intervention Type: DRUG

Medication instilled into the study eye, subjects randomized to various drug dose schedules.

Interventions

BOL-303242-X

Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.

Intervention Type: DRUG

Vehicle for BOL-303242-X

Medication instilled into the study eye, subjects randomized to various drug dose schedules.

Intervention Type: DRUG

Other Intervention Names

Mapracorat

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Trusso, MS

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Rochester, New York, United States

Countries

United States

Other Identifiers

588

Identifier Type: -

Identifier Source: org_study_id