rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.
Have the ability to comprehend and provide a signed and dated consent form.
Are 18-75 years at time of consent;
Have been diagnosed with SS for at least 3 months prior to ICF;
Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;
Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous/serum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;
Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.
Have only one eye;
Parallel
Recombinant Human Proteoglycan 4
DrugrhPRG4 450ug/ml
Vehicle Control
DrugPBS based Vehicle Conrtol
To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency & Corneal neo
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency \& Corneal neovascularization)
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
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