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.
Have the ability to comprehend and provide a signed and dated consent form.
Are 18-80 years of age at time of consent;
Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;
Current use of artificial tears for the treatment of oGVHD related dry eye;
are currently pregnant or,
have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
are breast-feeding or,
Crossover
rhPRG4 450ug/ml
DrugTreatment
Vehicle Control
DrugPBS Based Vehicle Control
To 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
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
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
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
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
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
Click on the lead sponsor to view all of their trials.
