Zylet vs TobraDex in Blepharokeratoconjunctivitis

Bausch + Lomb

Status and phase

Completed

Phase 4

Conditions

Blepharokeratoconjunctivitis

Treatments

Drug: Loteprednol etabonate and tobramycin ophthalmic suspension

Drug: Tobramycin and dexamethasone ophthalmic suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447577

512

Details and patient eligibility

About

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

Enrollment

276 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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