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COMPLETED Phase 4

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

NCT04521140 · View on ClinicalTrials.gov ↗

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.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04521140

The ClinicalTrials.gov registry entry for NCT04521140 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicole Fram M.D., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04521140 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04521140?

This trial is sponsored by Nicole Fram M.D., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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