To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to a standard steroid drop regimen in the contralateral eye for the treatment of ocular rosacea.
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye receives Dextenza (Group A) intracanalicular insert and the contralateral eye receives topical fluorometholone 0.1% BID (Group B) for 2 weeks then once daily for 2 weeks for the treatment of ocular rosacea. All patients will be placed on oral doxycycline 100mg BID for one month and tapered to a maintenance dose of 100mg once daily for the remainder of the study. Patient evaluations will be performed at Screening/Baseline, Insertion Day, Month 1 and Month 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dextenza 0.4Mg Ophthalmic Insert
Fluoromethalone .01%
Change in OSDI
As measured by OSDI questionnaire
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Patient preference in treatment therapy
As measured by Adapted COMTOL questionnaire
Time frame: Accessed at Week 4
Change in tear breakup time
As measured by Fluoroscein (Bioglo strip moistened with saline) placed in the inferior fornix of each eye. A cobalt blue light beam will be used to count the number of seconds between the last blink and the appearance of a dry spot or break in tear film.
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in Expression of Gland Scale
As measured by digitally compressing the lower and upper lids and quantified on a 4-point scale: (0- all five glands, 1 - three to four glands, 2 - one to two glands, 3 - zero glands). The values will be averaged for each eye.
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in corneal staining
As measured by the NEI/Industry Grading system
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
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