Overview

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

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Loteprednol Etabonate
Tobramycin
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.