Status:
COMPLETED
Zylet vs TobraDex in Blepharokeratoconjunctivitis
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Blepharokeratoconjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00447577
Start Date
January 1 2007
End Date
June 1 2007
Last Update
December 9 2011
Active Locations (1)
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1
Cornerstone Eye Care
High Point, North Carolina, United States, 27262