Back to resultsOcular 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
About this trial
This is an interventional treatment trial for Inflammation
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
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
NCT ID
NCT00532961
First Posted
September 20, 2007
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
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
Learn more about this trial
Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex
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