Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01028027
First received: December 8, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).


Condition Intervention Phase
Conjunctivitis
Keratitis
Blepharitis
Drug: Loteprednol and tobramycin
Drug: Tobramycin and dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
    The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).


Secondary Outcome Measures:
  • Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
    The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

  • Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]
    The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.

  • Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]
    The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

  • Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population [ Time Frame: Baseline, Day 3 ] [ Designated as safety issue: No ]
    The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.

  • Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population [ Time Frame: Baseline, Day 3 ] [ Designated as safety issue: No ]
    The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.


Enrollment: 357
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension
Drug: Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Other Name: Zylet
Active Comparator: Tobramycin and dexamethasone
Tobramycin and dexamethasone ophthalmic suspension
Drug: Tobramycin and dexamethasone
Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Other Name: Tobradex

  Eligibility

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

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of BKC in at least one eye
  • Subjects must be willing to discontinue contact lens use for the duration of the study
  • Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
  • Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
  • Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
  • Subjects having ocular surgery (including laser surgery) in either eye within the past three 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: NCT01028027

Locations
Singapore
Bausch & Lomb Inc
Singapore, Singapore, 556741
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Esther Chu 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: NCT01028027     History of Changes
Other Study ID Numbers: 617
Study First Received: December 8, 2009
Results First Received: July 14, 2011
Last Updated: February 27, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Blepharokeratoconjunctivitis

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

ClinicalTrials.gov processed this record on October 23, 2014