CompletedPhase 1/2

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

United States15 participantsStarted 2019-12-20

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

What they're measuring

Overall Response Rate

Timeframe: 30 days

Trial details

NCT IDNCT03298815

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-16

Results submitted2025-03-11

View on ClinicalTrials.gov More Ocular Graft Versus Host Disease trials