Zylet vs TobraDex in Blepharokeratoconjunctivitis

Completed · Phase 4

Conditions studied: Blepharokeratoconjunctivitis

In brief

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

Key facts

Study ID

NCT00447577

Run by

Bausch & Lomb Incorporated

People needed

276

Starts

2007-01-01

Expected to finish

2007-06-01

Last updated by the study team

2011-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornerstone Eye Care — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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