The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
137
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Topical ocular administration of Tobramycin QID for 14 days.
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Change From Baseline in the Total Blepharoconjunctivitis Grade.
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to 15 days
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to Day 3
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to Day 7
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Topical ocular administration of the vehicle of Zylet QID for 14 days.