NCT00905450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

May 19, 2009

Results QC Date

August 18, 2020

Last Update Submit

September 2, 2020

Conditions

CataractInflammation

Keywords

Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.

    8 days

Study Arms (2)

BOL-303242-X

EXPERIMENTAL

BOL-303242-X (Mapracorat)

Drug: BOL-303242-X

Vehicle

PLACEBO COMPARATOR

Vehicle for BOL-303242-X (Mapracorat)

Drug: Vehicle for BOL-303242-X

Interventions

BOL-303242-XDRUG

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

Also known as: Mapracorat
BOL-303242-X
Vehicle for BOL-303242-XDRUG

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

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

CataractInflammation

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Laura Trusso, MS

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

September 22, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-09

Locations

US(1)