Zylet vs TobraDex in Blepharokeratoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00447577
First received: March 12, 2007
Last updated: December 7, 2011
Last verified: December 2011
  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 suspension
Drug: Tobramycin and dexamethasone ophthalmic suspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

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 [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The distribution of Investigator global assessment at each visit. [ Time Frame: Visit 2, 3 & 4 ] [ Designated as safety issue: No ]
  • The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment. [ Time Frame: Visit 2, 3 & 4 ] [ Designated as safety issue: No ]
  • The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score. [ Time Frame: Visit 2 & 3 ] [ Designated as safety issue: No ]
  • The change from baseline to each visit in the signs composite score and the symptoms composite score. [ Time Frame: Visit 1, 2, 3 & 4 ] [ Designated as safety issue: No ]
  • The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score. [ Time Frame: Visit 1, 2, 3 & 4 ] [ Designated as safety issue: No ]
  • The change from baseline to each visit in individual signs and symptoms. [ Time Frame: Visit 1, 2, 3 & 4 ] [ Designated as safety issue: No ]
  • VA, Biomicroscopy, and IOP assessments at each visit [ Time Frame: Visit 1, 2, 3 & 4 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Visit 1, 2, 3 & 4 ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zylet
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)
Drug: 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.
Active Comparator: Tobradex
Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Incorporated
Investigators
Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00447577     History of Changes
Other Study ID Numbers: 512
Study First Received: March 12, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Tobramycin
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 18, 2014