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NCT04521140 · ClinicalTrials.gov registry record · Phase 4
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
A Phase 4 study of Intraocular Pressure and Corneal Edema, sponsored by Nicole Fram M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04521140: Completed Phase 4 study of Intraocular Pressure and Corneal Edema, sponsored by Nicole Fram M.D..
NCT04521140 is a Phase 4 study of Intraocular Pressure and Corneal Edema that has completed, run by Nicole Fram M.D.. The registered enrollment target is 36 participants, below the 84-participant average among 9 other Intraocular Pressure trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04521140, a Phase 4 study of Intraocular Pressure and Corneal Edema, has completed, sponsored by Nicole Fram M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
Primary Outcome
as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible
Conditions Studied
Interventions
- DRUG Prednisolone Acetate 1% Oph Susp
- DRUG Dextenza 0.4Mg Ophthalmic Insert
Study Locations (1)
California
- Advanced Vision Care - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2023-01-04 |
| Phase | Phase 4 |
What the finished NCT04521140 record still lists
NCT04521140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 84-participant average among 9 other Intraocular Pressure trials with a reported enrollment target (57% lower).
The record links to 7 conditions, with Intraocular Pressure appearing as the primary indexed condition, and to 2 interventions - of which Prednisolone Acetate 1% Oph Susp is the first listed.
NCT04521140 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04521140 about?
NCT04521140 is a clinical study titled "Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery". Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
What is the current status of trial NCT04521140?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2020-10-16. Estimated completion is 2023-01-04.
What conditions does trial NCT04521140 study?
This clinical trial studies the following conditions: Intraocular Pressure, Corneal Edema, Ocular Pain, Corneal Defect, Corneal Transplant.
What interventions are being tested in trial NCT04521140?
The interventions under investigation include: Prednisolone Acetate 1% Oph Susp (DRUG), Dextenza 0.4Mg Ophthalmic Insert (DRUG).
Who is sponsoring clinical trial NCT04521140?
This trial is sponsored by Nicole Fram M.D., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04521140 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Intraocular Pressure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04521140's enrollment target sits among peer trials
36 8th of 9 higher than 2 of 9 other Intraocular Pressure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intraocular Pressure 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.
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