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NCT03298815 · ClinicalTrials.gov registry record · Phase 1
Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03298815: Completed Phase 1 study, sponsored by University of Utah.
NCT03298815 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03298815, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.
Primary Outcome
Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.
Interventions
- OTHER Saline Solution
- BIOLOGICAL Amniotic Fluid Eye Drops (AFED)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2023-02-24 |
| Phase | Phase 1 |
What the finished NCT03298815 record still lists
NCT03298815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline Solution is the first listed.
NCT03298815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03298815 about?
NCT03298815 is a clinical study titled "Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)". A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.
What is the current status of trial NCT03298815?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-12-20. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT03298815?
The interventions under investigation include: Saline Solution (OTHER), Amniotic Fluid Eye Drops (AFED) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03298815?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03298815's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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