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Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

NCT03298815 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-09

Study results available
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Summary

A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.

Conditions

  • Ocular Graft Versus Host Disease

Interventions

BIOLOGICAL

Amniotic Fluid Eye Drops (AFED)

One drop (0.25 mL) in one eye twice daily for up to 3 months

OTHER

Saline Solution

One drop (0.25 mL) in the other eye twice daily for up to 3 months

Sponsors & Collaborators

Principal Investigators

  • Catherine J. Lee, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2022-12-16
Completion
2023-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298815 on ClinicalTrials.gov