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

Phase 3

Completed

Conditions: Conjunctivitis
Keratitis
Blepharitis

Interventions: Drug: Loteprednol and tobramycin
Drug: Tobramycin and dexamethasone

Registration Number: NCT01028027

Lead Sponsor: Bausch & Lomb Incorporated

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 357

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol and tobramycin	Loteprednol and tobramycin	Loteprednol etabonate and tobramycin ophthalmic suspension
Tobramycin and dexamethasone	Tobramycin and dexamethasone	Tobramycin and dexamethasone ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population	Baseline, Day 15	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

Name	Time	Method
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population	Baseline, Day 15	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	Baseline, Day 8	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	Baseline, Day 8	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	Baseline, Day 3	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	Baseline, Day 3	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.