Zylet vs TobraDex in Blepharokeratoconjunctivitis - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00447577

Purpose

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

Condition	Intervention	Phase
Blepharokeratoconjunctivitis	Drug: loteprednol etabonate and tobramycin ophthalmic solution Drug: tobramycin and dexamthasone ophthalmic suspension	Phase IV

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Loteprednol Loteprednol etabonate Tobramycin Tobramycin sulfate

U.S. FDA Resources

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

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	268
Study Start Date:	January 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447577

Locations

United States, North Carolina
Cornerstone Eye Care
High Point, North Carolina, United States, 27262

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Timothy Comstock, OD

Bausch & Lomb, Inc.

More Information

Publications indexed to this study:

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.

Study ID Numbers:	512
Study First Received:	March 12, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00447577
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Tobramycin
Loteprednol etabonate
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009