Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01028027
Collaborator
(none)
357
Enrollment
1
Location
2
Arms
5
Duration (Months)
72
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Loteprednol and tobramycin
  • Drug: Tobramycin and dexamethasone
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
357 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Loteprednol and tobramycin

Loteprednol etabonate and tobramycin ophthalmic suspension

Drug: Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Other Names:
  • Zylet
  • Active Comparator: Tobramycin and dexamethasone

    Tobramycin and dexamethasone ophthalmic suspension

    Drug: Tobramycin and dexamethasone
    Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
    Other Names:
  • Tobradex
  • Outcome Measures

    Primary Outcome Measures

    1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population [Baseline, Day 15]

      The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

    Secondary Outcome Measures

    1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population [Baseline, Day 15]

      The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

    2. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population [Baseline, Day 8]

      The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.

    3. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population [Baseline, Day 8]

      The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

    4. Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population [Baseline, Day 3]

      The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.

    5. Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population [Baseline, Day 3]

      The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must have a clinical diagnosis of BKC in at least one eye

    • Subjects must be willing to discontinue contact lens use for the duration of the study

    • Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

    Exclusion Criteria:
    • Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

    • Subjects who have any uncontrolled systemic disease or debilitating disease.

    • Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.

    • Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.

    • Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.

    • Subjects having ocular surgery (including laser surgery) in either eye within the past three months.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Bausch & Lomb IncSingaporeSingapore556741

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Esther Chu, Bausch & Lomb Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01028027
    Other Study ID Numbers:
    • 617
    First Posted:
    Dec 9, 2009
    Last Update Posted:
    Feb 28, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Bausch & Lomb Incorporated
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThis study was conducted at seven sites, by seven Investigators in the People's Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.
    Pre-assignment DetailA total of 357 participants with clinically diagnosed blepharokeratoconjunctivitis (BKC) in at least one eye were enrolled. 328 participants completed the study.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Period Title: Overall Study
    STARTED180177
    COMPLETED164164
    NOT COMPLETED1613

    Baseline Characteristics

    Arm/Group TitleLoteprednol and TobramycinTobramycin and DexamethasoneTotal
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Total of all reporting groups
    Overall Participants180177357
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    40.8
    (13.63)
    41.72
    (13.54)
    41.26
    (13.57)
    Sex: Female, Male (Count of Participants)
    Female
    123
    68.3%
    113
    63.8%
    236
    66.1%
    Male
    57
    31.7%
    64
    36.2%
    121
    33.9%
    Region of Enrollment (participants) [Number]
    Singapore
    180
    100%
    177
    100%
    357
    100%

    Outcome Measures

    1. Primary Outcome
    TitleSigns and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
    DescriptionThe change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
    Time FrameBaseline, Day 15

    Outcome Measure Data

    Analysis Population Description
    The PP population was the population used for the primary efficacy analysis.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants156152
    Mean (Standard Deviation) [Scores on a scale]
    -11.63
    (4.56)
    -12.41
    (4.71)
    2. Secondary Outcome
    TitleSigns and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
    DescriptionThe CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
    Time FrameBaseline, Day 15

    Outcome Measure Data

    Analysis Population Description
    The ITT population was used in this secondary efficacy parameter.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants164165
    Mean (Standard Deviation) [Score on a scale]
    -11.64
    (4.55)
    -11.98
    (4.95)
    3. Secondary Outcome
    TitleSigns and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
    DescriptionThe CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
    Time FrameBaseline, Day 8

    Outcome Measure Data

    Analysis Population Description
    The PP population was used for this secondary efficacy parameters.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants155150
    Mean (Standard Deviation) [Score on a scale]
    -9.20
    (3.94)
    -10.21
    (4.23)
    4. Secondary Outcome
    TitleSigns and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
    DescriptionThe CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
    Time FrameBaseline, Day 8

    Outcome Measure Data

    Analysis Population Description
    The ITT population was used in this secondary efficacy parameter.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants172171
    Mean (Standard Deviation) [Score on a scale]
    -8.91
    (4.24)
    -9.96
    (4.27)
    5. Secondary Outcome
    TitleSigns and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
    DescriptionThe CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.
    Time FrameBaseline, Day 3

    Outcome Measure Data

    Analysis Population Description
    The PP population was used for this secondary efficacy parameters.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants155152
    Mean (Standard Deviation) [Score on a scale]
    -5.66
    (3.46)
    -5.98
    (3.68)
    6. Secondary Outcome
    TitleSigns and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
    DescriptionThe CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.
    Time FrameBaseline, Day 3

    Outcome Measure Data

    Analysis Population Description
    The ITT population was used for this secondary efficacy parameters.
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    Measure Participants177176
    Mean (Standard Deviation) [Score on a scale]
    -5.54
    (3.48)
    -5.92
    (3.69)

    Adverse Events

    Time Frame14 days
    Adverse Event Reporting Description
    Arm/Group TitleLoteprednol and TobramycinTobramycin and Dexamethasone
    Arm/Group DescriptionLoteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
    All Cause Mortality
    Loteprednol and TobramycinTobramycin and Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Loteprednol and TobramycinTobramycin and Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/177 (0%) 0/177 (0%)
    Other (Not Including Serious) Adverse Events
    Loteprednol and TobramycinTobramycin and Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total16/177 (9%) 36/177 (20.3%)
    Eye disorders
    Increased IOP16/177 (9%) 5236/177 (20.3%) 52

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.

    Results Point of Contact

    Name/TitleTuyen Ong, MD
    OrganizationBausch & Lomb Incorporated
    Phone(973) 360-6389
    Emailtuyen.ong@bausch.com
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01028027
    Other Study ID Numbers:
    • 617
    First Posted:
    Dec 9, 2009
    Last Update Posted:
    Feb 28, 2012
    Last Verified:
    Feb 1, 2012