A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). At 90 minutes, Crossover group subjects will be administered rhPRG4, then evaluated 5 \& 30 minutes after rhPRG4 instillation (95 \& 120 minutes from baseline). All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
1-2 drops of rhPRG4 450 µg/mL solution in both eyes
Sterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20.
Sydney Eye Hospital
Sydney, Australia
• To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at 90 minutes
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events
Time frame: 90 minutes
• To assess the efficacy of rhPRG4 using the average VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS
Time frame: at 5 minutes, 30 minutes, 90 minutes, 4 & 8 hours
• To assess the efficacy of rhPRG4 using the minimum inter-eye non-invasive tear film breakup time (TBUT): min(OU)
Time frame: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using maximum inter-eye tear osmolarity: max(OU)
Time frame: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using a patient questionnaire
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE)
Time frame: 90 minutes
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