Clinical trial NCT01028027: Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Official title: A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Conjunctivitis
Keratitis
Blepharitis
Keywords: Blepharokeratoconjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
timeFrame: Baseline, Day 15
measure: Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
timeFrame: Baseline, Day 8
measure: Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
timeFrame: Baseline, Day 8
measure: Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
timeFrame: Baseline, Day 3
measure: Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
timeFrame: Baseline, Day 3
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Bausch & Lomb Inc
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Esther Chu
role: STUDY_DIRECTOR
References:
citation: Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.