NCT01591655

Brief Summary

The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

May 2, 2012

Results QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

CataractInflammationSurgery

Outcome Measures

Primary Outcomes (2)

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

    Anterior chamber (AC) cells were 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. 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

  • Percentage of Participants With Grade 0 Pain

    Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.

    8 days

Secondary Outcomes (5)

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

    15 days

  • Percentage of Participants With Grade 0 Pain

    15 days

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

    15 days

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

    15 days

  • Percentage of Treatment Failures

    8 days

Study Arms (2)

Mapracorat

EXPERIMENTAL

Mapracorat ophthalmic suspension, 3%,

Drug: Mapracorat

Vehicle

PLACEBO COMPARATOR

The vehicle of the mapracorat ophthalmic suspension

Drug: Vehicle

Interventions

MapracoratDRUG

1 drop of study medication into the study eye four times daily (QID) for 14 days

Mapracorat
VehicleDRUG

1 drop of vehicle into the study eye QID for 14 days.

Vehicle

Eligibility Criteria

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

You may qualify if:

  • Subjects who are candidates for routine, uncomplicated cataract surgery.
  • Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
  • Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

You may not qualify if:

  • Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
  • Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
  • Presence of active external ocular disease: infection or inflammation of the study eye.
  • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb, Incorporated

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

  • Quintus Ngumah, OD,PhD

    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 3
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 2, 2012

First Posted

May 4, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

September 3, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-08

Locations

US(1)