Zylet vs TobraDex in Blepharokeratoconjunctivitis

NCT ID: NCT00447577

Last Updated: 2011-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-06-30

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

Conditions

Blepharokeratoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zylet

Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)

Group Type: EXPERIMENTAL

Loteprednol etabonate and tobramycin ophthalmic suspension

Intervention Type: DRUG

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Tobradex

Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.

Group Type: ACTIVE_COMPARATOR

Tobramycin and dexamethasone ophthalmic suspension

Intervention Type: DRUG

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Interventions

Loteprednol etabonate and tobramycin ophthalmic suspension

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Intervention Type: DRUG

Tobramycin and dexamethasone ophthalmic suspension

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Comstock, OD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Cornerstone Eye Care

High Point, North Carolina, United States

Countries

United States

References

White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.

Reference Type: DERIVED

PMID: 18062846 (View on PubMed)

Other Identifiers

512

Identifier Type: -

Identifier Source: org_study_id