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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 Population

Signs 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

Page last updated: August 23, 2015

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