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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cataract
• Intervention / Treatment: Drug: BOL-303242-X; Drug: Vehicle for BOL-303242-X

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOL-303242-X; BOL-303242-X (Mapracorat)	Drug: BOL-303242-X; Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.; Other Names: Mapracorat
Placebo Comparator: Vehicle; Vehicle for BOL-303242-X (Mapracorat)	Drug: Vehicle for BOL-303242-X; Medication instilled into the study eye, subjects randomized to various drug dose schedules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	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.	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	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.	8 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Laura Trusso, MS, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 19, 2009
• First Posted (Estimate): May 20, 2009

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract
• Other Study ID Numbers: 588