The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
276
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Cornerstone Eye Care
High Point, North Carolina, United States
The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score
Time frame: 15 days
The distribution of Investigator global assessment at each visit.
Time frame: Visit 2, 3 & 4
The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.
Time frame: Visit 2, 3 & 4
The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score.
Time frame: Visit 2 & 3
The change from baseline to each visit in the signs composite score and the symptoms composite score.
Time frame: Visit 1, 2, 3 & 4
The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score.
Time frame: Visit 1, 2, 3 & 4
The change from baseline to each visit in individual signs and symptoms.
Time frame: Visit 1, 2, 3 & 4
VA, Biomicroscopy, and IOP assessments at each visit
Time frame: Visit 1, 2, 3 & 4
Adverse Events
Time frame: Visit 1, 2, 3 & 4
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