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

Phase 2

Completed

• Conditions: Cataract; Inflammation
• Interventions: Drug: Vehicle for BOL-303242-X; Drug: BOL-303242-X

• Registration Number: NCT00905450
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Study Start: 2009-06
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-05-04
• Disposition First Posted: 2011-05-06
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle for BOL-303242-X	Vehicle for BOL-303242-X (Mapracorat)
BOL-303242-X	BOL-303242-X	BOL-303242-X (Mapracorat)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	8 days	Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	8 days	A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States