A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 357
- Locations
- 1
- Primary Endpoint
- Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension
Intervention: Loteprednol and tobramycin (Drug)
Tobramycin and dexamethasone
Tobramycin and dexamethasone ophthalmic suspension
Intervention: Tobramycin and dexamethasone (Drug)
Outcomes
Primary Outcomes
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Time Frame: 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 Outcomes
- Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population(Baseline, Day 15)
- Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population(Baseline, Day 8)
- Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population(Baseline, Day 8)
- Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population(Baseline, Day 3)
- Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population(Baseline, Day 3)