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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 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.

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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%.

Interventions

  • DRUG Prednisolone Acetate 1% Oph Susp
  • DRUG Dextenza 0.4Mg Ophthalmic Insert

Study Locations (1)

California

  • Advanced Vision Care - Los Angeles

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2020-10-16
Est. Completion 2023-01-04
Phase Phase 4

Sponsor

Nicole Fram M.D.

4 total trials

What the Registry Record Tells You About NCT04521140

The ClinicalTrials.gov registry entry for NCT04521140 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 84-participant average among 9 other Intraocular Pressure trials with a reported enrollment target (57% lower). The listed sponsor is Nicole Fram M.D., which has 4 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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