Status:
COMPLETED
Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Lead Sponsor:
University of Utah
Conditions:
Ocular Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.
Detailed Description
This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have underg...
Eligibility Criteria
Inclusion
- Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms:
- Dry eye symptoms partially affecting (requiring lubricant drops \> 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
- Unable to work because of ocular symptoms
- Loss of vision due to keratoconjunctivitis sicca (KCS)
- Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- Patients who are 18 years of age or older.
- Willing and able to provide informed consent.
Exclusion
- Patients who have any other reversible cause for dry eye at the time of accrual.
- More than 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
- Relapsed malignancy at time of accrual after the most recent transplantation
- A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report
- Patients who are pregnant or plan to become pregnant while participating in the study.
- Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF.
- Inability to comply with the investigational plan and visit schedule for any reason, in the judgement of the investigator.
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03298815
Start Date
December 20 2019
End Date
February 24 2023
Last Update
April 9 2025
Active Locations (1)
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1
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112