The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.
This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Massachusetts Eye Research and Surgery Institution (MERSI)
Cambridge, Massachusetts, United States
Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
B-Berger and Associates
Austin, Texas, United States
Proportion of patients with anterior chamber cell ACC grade of zero
Time frame: Day 15
Number of patients with treatment-emergent adverse events
Time frame: 29 days
Proportion of patients with no uveitis symptoms
Time frame: 29 days
Proportion of patients with improvement in visual acuity
Change in ETDRS letter score
Time frame: 29 days
Change from baseline in anterior chamber cell (ACC) grade
Time frame: Day 8
Change from baseline in anterior chamber cell (ACC) grade
Time frame: Day 15
Change from baseline in anterior chamber cell (ACC) grade
Time frame: Day 29
Proportion of patients with anterior chamber cell ACC grade of zero
Time frame: Day 8
Proportion of patients with anterior chamber cell ACC grade of zero
Time frame: Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retina and Uveitis Consultants of Texas
San Antonio, Texas, United States
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States