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Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Loteprednol etabonate 0.5% and tobramycin 0.3%
Dexamethasone 0.1% and tobramycin 0.3%
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • in good general health based on investigator judgment
  • able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
  • possessing a best corrected visual acuity of at least 20/40 in each eye
  • for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion Criteria:

  • contact lenses worn within 30 days prior to enrollment or during study period
  • known hypersensitivity to study medication or any component
  • presence of significant ocular or systemic disease that might interfere with the interpretation of the results
  • a need for administration of chronic topical ocular or systemic medications of any kind during the study.
  • participation in an opthalmic drug or device research study within 30 days prior to entry

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Zylet

    Tobradex

    Arm Description

    Zylet (loteprednol etabonate and tobramycin)

    TobraDex (dexamethasone and tobramycin)

    Outcomes

    Primary Outcome Measures

    Ocular comfort/tolerability
    Intraocular pressure measurements

    Secondary Outcome Measures

    Assessment of safety

    Full Information

    First Posted
    September 20, 2007
    Last Updated
    December 7, 2011
    Sponsor
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00532961
    Brief Title
    Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex
    Official Title
    A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    April 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    310 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zylet
    Arm Type
    Experimental
    Arm Description
    Zylet (loteprednol etabonate and tobramycin)
    Arm Title
    Tobradex
    Arm Type
    Active Comparator
    Arm Description
    TobraDex (dexamethasone and tobramycin)
    Intervention Type
    Drug
    Intervention Name(s)
    Loteprednol etabonate 0.5% and tobramycin 0.3%
    Other Intervention Name(s)
    Zylet
    Intervention Description
    ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone 0.1% and tobramycin 0.3%
    Other Intervention Name(s)
    TobraDex
    Intervention Description
    ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.
    Primary Outcome Measure Information:
    Title
    Ocular comfort/tolerability
    Time Frame
    Day 1, 3, 8, 15, 22 and 29
    Title
    Intraocular pressure measurements
    Time Frame
    Day 1, 3, 8,15, 22 and 29
    Secondary Outcome Measure Information:
    Title
    Assessment of safety
    Time Frame
    Througout 28-day study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: in good general health based on investigator judgment able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study possessing a best corrected visual acuity of at least 20/40 in each eye for females, using reliable contraception and a negative urine pregnancy test prior to study entry Exclusion Criteria: contact lenses worn within 30 days prior to enrollment or during study period known hypersensitivity to study medication or any component presence of significant ocular or systemic disease that might interfere with the interpretation of the results a need for administration of chronic topical ocular or systemic medications of any kind during the study. participation in an opthalmic drug or device research study within 30 days prior to entry
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy L Comstock, DO
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18577309
    Citation
    Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.
    Results Reference
    derived

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    Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

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