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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 is a Phase 4 study that has completed, run by Price Vision Group. The registered enrollment target is 70 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05136443
The ClinicalTrials.gov registry entry for NCT05136443 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Price Vision Group, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which loteprednol etabonate 0.25% ophthalmic suspension is the first listed.
NCT05136443 reports 0 study locations.
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.
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