RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD) (NCT06495307) | Clinical Trial Compass
TerminatedPhase 1/2
RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Stopped: Efficacy signal substantial enough to more to larger study
Australia3 participantsStarted 2025-02-14
Plain-language summary
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Subjects 18 years of age or older;
✓. Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
✓. VAS Eye Dryness (100-point scale) score ≥ 60 mm;
✓. Tear Osmolarity ≥ 312 in either eye;
✓. Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
✓. Only subjects who satisfy all Informed Consent requirements may be included in the study.
Exclusion criteria
✕. Evidence of an active ocular infection in either eye;
✕. History or presence of ocular surface disorders not related to oGVHD in either eye, including but not limited to significant 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 and moderate to severe blepharitis;
✕. History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 90 days before study enrollment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period;
✕. Initiation of new therapeutic modalities within 30 days of recruitment;
What they're measuring
1
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 Day 28
Timeframe: 28
2
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28
Timeframe: 28
3
To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events