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

Study Overview
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Brief Summary
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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).

Official Title
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A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis

Conditions
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Conjunctivitis, Keratitis, Blepharitis

Intervention / Treatment
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* Drug: Loteprednol and tobramycin
* Drug: Tobramycin and dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol and tobramycin<br>Loteprednol etabonate and tobramycin ophthalmic suspension | Drug: Loteprednol and tobramycin<br>* Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.<br>* Other names: Zylet;|
| Active Comparator: Tobramycin and dexamethasone<br>Tobramycin and dexamethasone ophthalmic suspension | Drug: Tobramycin and dexamethasone<br>* Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.<br>* Other names: Tobradex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population | 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). | Baseline, Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population | 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 | Baseline, Day 15 | 
| Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population | 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. | Baseline, Day 8 | 
| Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population | 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 | Baseline, Day 8 | 
| Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population | 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. | Baseline, Day 3 | 
| Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population | 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. | Baseline, Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharokeratoconjunctivitis