Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conjunctivitis; Keratitis; Blepharitis
Intervention: Loteprednol and tobramycin (Drug); Tobramycin and dexamethasone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s): Esther Chu, Study Director, Affiliation: Bausch & Lomb Incorporated
Summary
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).
Clinical Details
Official title: A Clinical Safety and Efficacy Evaluation of ZyletŪ Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Secondary outcome: Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT PopulationSigns and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Bausch & Lomb Inc, Singapore 556741, Singapore
Additional Information
Starting date: October 2009
Last updated: February 27, 2012
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