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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammation

Intervention / Treatment
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* Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%
* Drug: Dexamethasone 0.1% and tobramycin 0.3%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zylet<br>Zylet (loteprednol etabonate and tobramycin) | Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%<br>* ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days<br>* Other names: Zylet;|
| Active Comparator: Tobradex<br>TobraDex (dexamethasone and tobramycin) | Drug: Dexamethasone 0.1% and tobramycin 0.3%<br>* ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.<br>* Other names: TobraDex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular comfort/tolerability |  | Day 1, 3, 8, 15, 22 and 29 | 
| Intraocular pressure measurements |  | Day 1, 3, 8,15, 22 and 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety |  | Througout 28-day study |