An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Treatment
PBS Based Vehicle Control
Sydney Eye Hospital
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGOTA
Brisbane, Queensland, Australia
RECRUITINGRoyal Melbourne Hospital
Melbourne, Victoria, Australia
RECRUITINGTo assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
Time frame: Baseline to day 28
To assess the efficacy of rhPRG4 using the total VAS score (sum of dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia, anchors: none & severe) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the total VAS score (sum of dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia, anchors: none \& severe) compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using individual VAS scores for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using individual VAS scores for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none \& severe) compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of signs evaluated by safety examination (ophthalmic examination plus slit lamp examination (SLE) of meibomian glands, eyelid Erythema, eyelid oedema, lashes, conjunctival erythema, lens, iris, anterior chamb
To assess the safety of rhPRG4 by observation of signs evaluated by safety examination (ophthalmic examination plus slit lamp examination (SLE) of meibomian glands, eyelid Erythema, eyelid oedema, lashes, conjunctival erythema, lens, iris, anterior chamber, hyperemia, corneal transparency \& corneal neovascularization)
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Time frame: From baseline to day 28
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