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Amniotic Fluid Eye Drops (AFED) - All participants, One eye for Graft Versus Host Disease of the Eye

Phase 1 & 2

Waitlist Available

Led By John Phillips, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days

Awards & highlights

Study Summary

This trial is testing whether a new eye drop can help treat a condition called Chronic Graft Versus Host Disease.

Eligible Conditions

Graft Versus Host Disease (GVHD) of the Eye

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Safety of pAF in patients with chronic ocular GVHD: CTCAE version 4

Secondary outcome measures

Changes in Visual Acuity

Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading

Effects on the Corneal Surface

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Amniotic Fluid Eye Drops (AFED) - All participants, One eyeActive Control1 Intervention

Group II: Saline Solution - All participants, One eyePlacebo Group1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of UtahLead Sponsor

1,094 Previous Clinical Trials

1,775,502 Total Patients Enrolled

John Phillips, PhDPrincipal InvestigatorUniversity of Utah

1 Previous Clinical Trials

255 Total Patients Enrolled

Catherine J. Lee, MDPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can the study accommodate at maximum capacity?

"Affirmative. According to clinicaltrials.gov, this research endeavour was first made available on December 20th 2019 and is currently looking for volunteers. 15 participants are being sought after from a single medical facility."

Answered by AI

Is there any availability for participants in this investigation?

"Affirmative. As per the clinicaltrials.gov record, this research is actively enrolling participants now. The initial posting was on December 20th 2019 and it has been updated most recently on August 29th 2022. 15 people are needed for this project across a single medical site."

Answered by AI

What is the ultimate outcome this clinical trial hopes to realize?

"This medical trial, which has a duration of 100 days, primarily seeks to assess the safety of pAF in patients with chronic ocular GVHD according to CTCAE version 4. Secondary objectives encompass changes in visual acuity and dry eye severity (according to DEWS 2007) as well as potential effects on the corneal surface."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Catherine Lee 2019. "Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03298815.