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

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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)

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
Vance Thompson Vision - MT

1 total trials

What NCT04549935 shows while recruiting

NCT04549935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Similar trials for Patient Preference

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 NCT04549935's enrollment target sits among peer trials

20 1753rd of 2000 higher than 168 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 NCT04549935, the US trial registry maintained by the National Library of Medicine. NCT04549935 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.