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NCT04281004 · ClinicalTrials.gov registry record · Phase 1
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
A Phase 1 study of Photorefractive Keratectomy, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT04281004: Completed Phase 1 study of Photorefractive Keratectomy, sponsored by University of Utah.
NCT04281004 is a Phase 1 study of Photorefractive Keratectomy that has completed, run by University of Utah. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04281004, a Phase 1 study of Photorefractive Keratectomy, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Primary Outcome
Ocular adverse events using MedDRA and CTCAE and serious adverse events
Conditions Studied
Interventions
- BIOLOGICAL Amniotic Fluid (AFED)
- OTHER Saline Solution
Study Locations (1)
Utah
- Moran Eye Center, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2023-01-16 |
| Phase | Phase 1 |
What the finished NCT04281004 record still lists
NCT04281004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Photorefractive Keratectomy appearing as the primary indexed condition, and to 2 interventions - of which Amniotic Fluid (AFED) is the first listed.
NCT04281004 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04281004 about?
NCT04281004 is a clinical study titled "Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)". This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
What is the current status of trial NCT04281004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2020-07-10. Estimated completion is 2023-01-16.
What conditions does trial NCT04281004 study?
This clinical trial studies the following conditions: Photorefractive Keratectomy.
What interventions are being tested in trial NCT04281004?
The interventions under investigation include: Amniotic Fluid (AFED) (BIOLOGICAL), Saline Solution (OTHER).
Who is sponsoring clinical trial NCT04281004?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04281004 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04281004's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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