Official Title: “A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3% vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension, 0.3%/0.1%) in the Treatment of Blepharokeratoconjunctivitis”

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: loteprednol etabonate and tobramycin ophthalmic solution
• Drug: tobramycin and dexamthasone ophthalmic suspension

Primary Measures

• The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score

Secondary Measures

• The distribution of Investigator global assessment at each visit.
• The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.
• The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score.
• The change from baseline to each visit in the signs composite score and the symptoms composite score.
• The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score.
• The change from baseline to each visit in individual signs and symptoms.
• Safety endpoints include:
• VA, Biomicroscopy, and IOP assessments at each visit
• Adverse Events

Inclusion Criteria:

• Must be at least 18 years of age
• Must be able and willing to comply with all treatment and follow up procedures
• Must have the ability to understand and sign an Informed Consent Form and provide
• Health Insurance Portability and Accountability Act (HIPAA) authorization
• Must be able to self-administer drugs
• Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
• Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
• Must be willing to discontinue contact lens use for the duration of the study
• Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

Exclusion Criteria:

• Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
• Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
• Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
• Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
• Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
• Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
• Suspected dacrocystitis
• Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
• Ocular surgery (including laser surgery) in either eye within the past 3 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bausch & Lomb, Inc.

Overall Clinical Trial Officials and Contacts

Timothy Comstock, OD Study Director Bausch & Lomb, Inc.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00447577

Study ID Number: 512

ClinicalTrials.gov Identifier: NCT00447577

Health Authority: United States: Food and Drug Administration