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NCT05136443 · ClinicalTrials.gov registry record · Phase 4
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
A Phase 4 study, sponsored by Price Vision Group.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT05136443: Completed Phase 4 study, sponsored by Price Vision Group.
NCT05136443 is a Phase 4 study that has completed, run by Price Vision Group. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05136443, a Phase 4 study, has completed, sponsored by Price Vision Group.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
Primary Outcome
incidence of immunologic rejection episodes
Interventions
- DRUG loteprednol etabonate 0.25% ophthalmic suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2023-09-05 |
| Phase | Phase 4 |
What the finished NCT05136443 record still lists
NCT05136443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which loteprednol etabonate 0.25% ophthalmic suspension is the first listed.
NCT05136443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05136443 about?
NCT05136443 is a clinical study titled "Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection". The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing an...
What is the current status of trial NCT05136443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2021-11-23. Estimated completion is 2023-09-05.
What interventions are being tested in trial NCT05136443?
The interventions under investigation include: loteprednol etabonate 0.25% ophthalmic suspension (DRUG).
Who is sponsoring clinical trial NCT05136443?
This trial is sponsored by Price Vision Group, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05136443's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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