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NCT05626478 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Nicole Fram M.D..

Completed
Registry status
Phase 4
Development phase
50
Enrollment target

NCT05626478: Completed Phase 4 study, sponsored by Nicole Fram M.D..

NCT05626478 is a Phase 4 study that has completed, run by Nicole Fram M.D.. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05626478, a Phase 4 study, has completed, sponsored by Nicole Fram M.D..

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target

Study Summary

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

Primary Outcome

Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.

Interventions

  • DRUG Prednisolone Acetate 1% Oph Susp
  • DRUG Dextenza 0.4Mg Ophthalmic Insert
  • DRUG Prolensa 0.07% Ophthalmic Solution

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-06-01
Est. Completion 2025-02-05
Phase Phase 4
Nicole Fram M.D.

4 total trials

What the finished NCT05626478 record still lists

NCT05626478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which Prednisolone Acetate 1% Oph Susp is the first listed.

NCT05626478 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05626478 about?

NCT05626478 is a clinical study titled "Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery". Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

What is the current status of trial NCT05626478?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-06-01. Estimated completion is 2025-02-05.

What interventions are being tested in trial NCT05626478?

The interventions under investigation include: Prednisolone Acetate 1% Oph Susp (DRUG), Dextenza 0.4Mg Ophthalmic Insert (DRUG), Prolensa 0.07% Ophthalmic Solution (DRUG).

Who is sponsoring clinical trial NCT05626478?

This trial is sponsored by Nicole Fram M.D., which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05626478's enrollment target sits among peer trials

50 1255th of 2000 higher than 678 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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Source: ClinicalTrials.gov NCT05626478, the US trial registry maintained by the National Library of Medicine. NCT05626478 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.