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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00905450
Collaborator
(none)
415
Enrollment
1
Location
2
Arms
11
Duration (Months)
37.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
415 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

ArmIntervention/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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Bausch & LombRochesterNew YorkUnited States14609

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00905450
    Other Study ID Numbers:
    • 588
    First Posted:
    May 20, 2009
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Bausch & Lomb Incorporated
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Arm/Group DescriptionBOL-303242-X ophthalmic suspension 1% Twice a DayBOL-303242-X ophthalmic suspension 2% Once a DayBOL-303242-X ophthalmic suspension 2% Twice a DayBOL-303242-X ophthalmic suspension 2% Four times a DayBOL-303242-X ophthalmic suspension 3% Once a DayBOL-303242-X ophthalmic suspension 3% Twice a DayBOL-303242-X ophthalmic suspension 3% Four times a DayVehicle for BOL-303242-X ophthalmic suspension
    Period Title: Overall Study
    STARTED6028286059606060
    COMPLETED5927286059585859
    NOT COMPLETED11000221

    Baseline Characteristics

    Arm/Group Title1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicleTotal
    Arm/Group DescriptionBOL-303242-X ophthalmic suspension 1% Twice a DayBOL-303242-X ophthalmic suspension 2% Once a DayBOL-303242-X ophthalmic suspension 2% Twice a DayBOL-303242-X ophthalmic suspension 2% Four times a DayBOL-303242-X ophthalmic suspension 3% Once a DayBOL-303242-X ophthalmic suspension 3% Twice a DayBOL-303242-X ophthalmic suspension 3% Four times a DayVehicle for BOL-303242-X ophthalmic suspensionTotal of all reporting groups
    Overall Participants6028286059606060415
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.4
    (12.0)
    67.9
    (10.9)
    68.9
    (10.5)
    69.5
    (7.1)
    68.2
    (10.8)
    67.3
    (10.7)
    68.5
    (10.3)
    67.1
    (10.8)
    67.8
    (10.4)
    Sex: Female, Male (Count of Participants)
    Female
    33
    55%
    15
    53.6%
    15
    53.6%
    34
    56.7%
    30
    50.8%
    32
    53.3%
    31
    51.7%
    32
    53.3%
    222
    53.5%
    Male
    27
    45%
    13
    46.4%
    13
    46.4%
    26
    43.3%
    29
    49.2%
    28
    46.7%
    29
    48.3%
    28
    46.7%
    193
    46.5%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Arm/Group DescriptionBOL-303242-X ophthalmic suspension 1% Twice a DayBOL-303242-X ophthalmic suspension 2% Once a DayBOL-303242-X ophthalmic suspension 2% Twice a DayBOL-303242-X ophthalmic suspension 2% Four times a DayBOL-303242-X ophthalmic suspension 3% Once a DayBOL-303242-X ophthalmic suspension 3% Twice a DayBOL-303242-X ophthalmic suspension 3% Four times a DayVehicle for BOL-303242-X ophthalmic suspension
    Measure Participants6028286059606060
    Count of Participants [Participants]
    35
    58.3%
    19
    67.9%
    15
    53.6%
    47
    78.3%
    42
    71.2%
    45
    75%
    42
    70%
    30
    50%
    2. Secondary Outcome
    TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
    DescriptionA 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.
    Time Frame8 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Arm/Group DescriptionBOL-303242-X ophthalmic suspension 1% Twice a DayBOL-303242-X ophthalmic suspension 2% Once a DayBOL-303242-X ophthalmic suspension 2% Twice a DayBOL-303242-X ophthalmic suspension 2% Four times a DayBOL-303242-X ophthalmic suspension 3% Once a DayBOL-303242-X ophthalmic suspension 3% Twice a DayBOL-303242-X ophthalmic suspension 3% Four times a DayVehicle for BOL-303242-X ophthalmic suspension
    Measure Participants6028286059606060
    Count of Participants [Participants]
    15
    25%
    6
    21.4%
    7
    25%
    18
    30%
    21
    35.6%
    23
    38.3%
    18
    30%
    11
    18.3%

    Adverse Events

    Time Frame18 days
    Adverse Event Reporting Description
    Arm/Group Title1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Arm/Group DescriptionBOL-303242-X ophthalmic suspension 1% Twice a DayBOL-303242-X ophthalmic suspension 2% Once a DayBOL-303242-X ophthalmic suspension 2% Twice a DayBOL-303242-X ophthalmic suspension 2% Four times a DayBOL-303242-X ophthalmic suspension 3% Once a DayBOL-303242-X ophthalmic suspension 3% Twice a DayBOL-303242-X ophthalmic suspension 3% Four times a DayVehicle for BOL-303242-X ophthalmic suspension
    All Cause Mortality
    1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/60 (0%) 0/28 (0%) 0/28 (0%) 0/60 (0%) 1/59 (1.7%) 1/60 (1.7%) 0/60 (0%) 0/60 (0%)
    Eye disorders
    Cystoid macular edema0/60 (0%) 0/28 (0%) 0/28 (0%) 0/60 (0%) 1/59 (1.7%) 0/60 (0%) 0/60 (0%) 0/60 (0%)
    Subretinal neovascularization0/60 (0%) 0/28 (0%) 0/28 (0%) 0/60 (0%) 0/59 (0%) 1/60 (1.7%) 0/60 (0%) 0/60 (0%)
    Other (Not Including Serious) Adverse Events
    1% Twice a Day2% Once a Day2% Twice a Day2% Four Times a Day3% Once a Day3% Twice a Day3% Four Times a DayVehicle
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total43/60 (71.7%) 20/28 (71.4%) 7/28 (25%) 18/60 (30%) 11/59 (18.6%) 25/60 (41.7%) 21/60 (35%) 37/60 (61.7%)
    Eye disorders
    Eye pain7/60 (11.7%) 4/28 (14.3%) 2/28 (7.1%) 0/60 (0%) 3/59 (5.1%) 2/60 (3.3%) 2/60 (3.3%) 6/60 (10%)
    Photophobia7/60 (11.7%) 4/28 (14.3%) 0/28 (0%) 1/60 (1.7%) 1/59 (1.7%) 4/60 (6.7%) 4/60 (6.7%) 5/60 (8.3%)
    AC Inflammation2/60 (3.3%) 1/28 (3.6%) 0/28 (0%) 2/60 (3.3%) 1/59 (1.7%) 3/60 (5%) 2/60 (3.3%) 4/60 (6.7%)
    Ocular hyperaemia5/60 (8.3%) 1/28 (3.6%) 0/28 (0%) 1/60 (1.7%) 1/59 (1.7%) 2/60 (3.3%) 3/60 (5%) 2/60 (3.3%)
    Lacrimation increased3/60 (5%) 2/28 (7.1%) 0/28 (0%) 2/60 (3.3%) 1/59 (1.7%) 2/60 (3.3%) 2/60 (3.3%) 2/60 (3.3%)
    Corneal edema2/60 (3.3%) 4/28 (14.3%) 1/28 (3.6%) 1/60 (1.7%) 0/59 (0%) 1/60 (1.7%) 1/60 (1.7%) 3/60 (5%)
    Foreign body sensation in eyes4/60 (6.7%) 0/28 (0%) 0/28 (0%) 1/60 (1.7%) 0/59 (0%) 2/60 (3.3%) 3/60 (5%) 2/60 (3.3%)
    Dry eye3/60 (5%) 2/28 (7.1%) 0/28 (0%) 1/60 (1.7%) 0/59 (0%) 2/60 (3.3%) 1/60 (1.7%) 0/60 (0%)
    Eye pruritis4/60 (6.7%) 2/28 (7.1%) 0/28 (0%) 0/60 (0%) 1/59 (1.7%) 1/60 (1.7%) 1/60 (1.7%) 0/60 (0%)
    Iritis0/60 (0%) 0/28 (0%) 1/28 (3.6%) 1/60 (1.7%) 1/59 (1.7%) 1/60 (1.7%) 1/60 (1.7%) 4/60 (6.7%)
    Conjunctival hyperemia1/60 (1.7%) 0/28 (0%) 1/28 (3.6%) 0/60 (0%) 1/59 (1.7%) 0/60 (0%) 0/60 (0%) 3/60 (5%)
    AC Flare0/60 (0%) 0/28 (0%) 2/28 (7.1%) 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%)
    Eye inflammation0/60 (0%) 0/28 (0%) 0/28 (0%) 0/60 (0%) 0/59 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%)
    Ciliary hyperemia1/60 (1.7%) 0/28 (0%) 0/28 (0%) 2/60 (3.3%) 0/59 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%)
    Investigations
    Intraocular pressure increased2/60 (3.3%) 0/28 (0%) 0/28 (0%) 2/60 (3.3%) 0/59 (0%) 1/60 (1.7%) 1/60 (1.7%) 3/60 (5%)
    Nervous system disorders
    Headache2/60 (3.3%) 0/28 (0%) 0/28 (0%) 4/60 (6.7%) 1/59 (1.7%) 1/60 (1.7%) 0/60 (0%) 0/60 (0%)

    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:
    NCT00905450
    Other Study ID Numbers:
    • 588
    First Posted:
    May 20, 2009
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020