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

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Blepharitis

Conjunctivitis

Keratitis

Treatments

Drug: Loteprednol and tobramycin

Drug: Tobramycin and dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028027

617

Details and patient eligibility

About

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).

Enrollment

357 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.