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NCT04015219 · ClinicalTrials.gov registry record · NA
Management of Signs and Symptoms Associated With Dry Eye Disease
A NA study, sponsored by BioTissue Holdings.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04015219: Clinical Trial NA study, sponsored by BioTissue Holdings.
NCT04015219 is a NA study that was terminated before completion, run by BioTissue Holdings. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015219, a NA study, was terminated before completion, sponsored by BioTissue Holdings.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
Primary Outcome
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
Interventions
- DEVICE Self retained cryopreserved amniotic membrane
- OTHER lifitegrast ophthalmic solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2020-10-05 |
| Phase | NA |
Why NCT04015219 stopped before completion
NCT04015219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Self retained cryopreserved amniotic membrane is the first listed.
NCT04015219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04015219 about?
NCT04015219 is a clinical study titled "Management of Signs and Symptoms Associated With Dry Eye Disease". A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recrui...
What is the current status of trial NCT04015219?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2018-07-18. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT04015219?
The interventions under investigation include: Self retained cryopreserved amniotic membrane (DEVICE), lifitegrast ophthalmic solution (OTHER).
Who is sponsoring clinical trial NCT04015219?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04015219's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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