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NCT04549935 · ClinicalTrials.gov registry record · Phase 4

The PRIME Study: A Randomized, Controlled, Prospective Study

A Phase 4 study of Patient Preference and Patient Outcomes, sponsored by Vance Thompson Vision - MT.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT04549935 is a Phase 4 study of Patient Preference and Patient Outcomes that is actively recruiting participants, run by Vance Thompson Vision - MT. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04549935, a Phase 4 study of Patient Preference and Patient Outcomes, is actively recruiting participants, sponsored by Vance Thompson Vision - MT.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Interventions

  • DRUG Dextenza
  • DRUG Topical Prednisolone

Study Locations (1)

Montana

  • Briana Parker - Bozeman

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-09-14
Est. Completion 2021-08-27
Phase Phase 4

Sponsor

Vance Thompson Vision - MT

1 total trials

What the Registry Record Tells You About NCT04549935

The ClinicalTrials.gov registry entry for NCT04549935 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vance Thompson Vision - MT, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Patient Preference appearing as the primary indexed condition, and to 2 interventions - of which Dextenza is the first listed.

NCT04549935 reports 1 study location spanning 1 distinct geographic area - top geographies include Montana.

Frequently Asked Questions

What is clinical trial NCT04549935 about?

NCT04549935 is a clinical study titled "The PRIME Study: A Randomized, Controlled, Prospective Study". To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin...

What is the current status of trial NCT04549935?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-09-14. Estimated completion is 2021-08-27.

What conditions does trial NCT04549935 study?

This clinical trial studies the following conditions: Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema.

What interventions are being tested in trial NCT04549935?

The interventions under investigation include: Dextenza (DRUG), Topical Prednisolone (DRUG).

Who is sponsoring clinical trial NCT04549935?

This trial is sponsored by Vance Thompson Vision - MT, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04549935 being conducted?

This trial has 1 study location across Montana. 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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