Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT01298752
Collaborator
(none)
177
Enrollment
1
Location
2
Arms
9
Duration (Months)
19.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
177 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mapracorat

Mapracorat ophthalmic suspension

Drug: Mapracorat
Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
Other Names:
  • BOL-303242-X
  • Placebo Comparator: Vehicle

    Vehicle of mapracorat ophthalmic suspension

    Drug: Vehicle
    Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. [8 days]

      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.

    2. Percentage of Participants With Grade 0 Pain [8 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects who are candidates for routine, uncomplicated cataract surgery.

    • Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

    Exclusion Criteria:
    • Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.

    • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.

    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Bausch & Lomb IncorporatedRochesterNew YorkUnited States14609

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Rabia Ozden, MD, Bausch & Lomb Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01298752
    Other Study ID Numbers:
    • 664
    First Posted:
    Feb 18, 2011
    Last Update Posted:
    Sep 3, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleMapracoratVehicle
    Arm/Group DescriptionMapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
    Period Title: Overall Study
    STARTED12057
    COMPLETED7731
    NOT COMPLETED4326

    Baseline Characteristics

    Arm/Group TitleMapracoratVehicleTotal
    Arm/Group DescriptionMapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.Total of all reporting groups
    Overall Participants12057177
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.5
    (9.72)
    63.2
    (12.29)
    65.4
    (10.69)
    Sex: Female, Male (Count of Participants)
    Female
    75
    62.5%
    30
    52.6%
    105
    59.3%
    Male
    45
    37.5%
    27
    47.4%
    72
    40.7%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
    DescriptionAnterior 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.
    Time Frame8 days

    Outcome Measure Data

    Analysis Population Description
    Randomized participants were included without imputation of missing data at 8 days.
    Arm/Group TitleMapracoratVehicle
    Arm/Group DescriptionMapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
    Measure Participants11454
    Count of Participants [Participants]
    9
    7.5%
    6
    10.5%
    2. Primary Outcome
    TitlePercentage of Participants With Grade 0 Pain
    DescriptionOcular 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.
    Time Frame8 days

    Outcome Measure Data

    Analysis Population Description
    Randomized participants were included without imputation of missing data at 8 days.
    Arm/Group TitleMapracoratVehicle
    Arm/Group DescriptionMapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
    Measure Participants11454
    Count of Participants [Participants]
    65
    54.2%
    27
    47.4%

    Adverse Events

    Time Frame18 days
    Adverse Event Reporting Description
    Arm/Group TitleMapracoratVehicle
    Arm/Group DescriptionMapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
    All Cause Mortality
    MapracoratVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    MapracoratVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/120 (0%) 0/57 (0%)
    Other (Not Including Serious) Adverse Events
    MapracoratVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total5/120 (4.2%) 6/57 (10.5%)
    Eye disorders
    Eye pain5/120 (4.2%) 6/57 (10.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Contact sponsor directly for details.

    Results Point of Contact

    Name/TitleStudy Director
    OrganizationBausch Health
    Phone
    Emailsusan.harris@bauschhealth.com
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01298752
    Other Study ID Numbers:
    • 664
    First Posted:
    Feb 18, 2011
    Last Update Posted:
    Sep 3, 2020
    Last Verified:
    Aug 1, 2020