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)

Recruiting Phase 2 Interventional Study
Ocular Graft Versus Host Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Lubris Bio Pty Ltd · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Have the ability to comprehend and provide a signed and dated consent form. 2. Are 18-80 years of age at time of consent; 3. Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial; 4. Current use of artificial tears f…
Contacts

Edward CEO

6193394016

ertruitt@lubris.net

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