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

A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis

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).

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.