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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.
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)
Conditions Studied
Interventions
- DRUG Dextenza
- DRUG Topical Prednisolone
Study Locations (1)
Montana
- Briana Parker - Bozeman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 4 |
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.
Learn More About Clinical Trials
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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