A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY O… (NCT07118254) | Clinical Trial Compass
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Australia15 participantsStarted 2025-09-17
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Have been stably using systemic medications for at least 14 days prior to Visit 1;
✓. VAS Eye Dryness (100-point scale) score ≥ 40 mm;
✓. Average VAS score for all symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \< 5 mm;
✓. Have Oxford corneal fluorescein staining grade of ≥ 2 using the Oxford scale in the worst performing eye
Exclusion criteria
✕. 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,
✕
What they're measuring
1
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
Timeframe: Baseline to day 28
2
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
. not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods; 8. Per the discretion of the investigator or designee, history of a serious physical or mental disorder that prevents the subject from attending study visits, complying with study-related procedures, and/or prevents the subject's ability to make decisions on their own; 9. Any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.