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NCT04781335 · ClinicalTrials.gov registry record · Phase 4
"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"
A Phase 4 study, sponsored by The Eye Institute of West Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT04781335: Completed Phase 4 study, sponsored by The Eye Institute of West Florida.
NCT04781335 is a Phase 4 study that has completed, run by The Eye Institute of West Florida. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04781335, a Phase 4 study, has completed, sponsored by The Eye Institute of West Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corneal and macular edema and pain management. There are several FDA approved agents either for topical use as single drug delivery or combination solutions for topical use as well; furthermore, there are slow release vehicles that may be placed at the time of surgery or postoperatively (at the lower punctum). The latter provides a less intense and demanding drop schedule and may improve patient compliance.
Primary Outcome
Concerning the outcome measures of pain we are going to use NRS pain (numeric rating scale score) that takes a minute to do, it is a subjective measure of pain that the patient is experiencing, the patient circles a number between 0 and 10 (0 no pain and 10 worse pain imaginable). Score 0 will be considered as no pain and any score equal or more than 5 will be considered as moderate to severe pain.
Interventions
- DRUG Dexycu
- DRUG Standard of Care post operative eye drops (steroid, antibiotic, NSAID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 4 |
What the finished NCT04781335 record still lists
NCT04781335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexycu is the first listed.
NCT04781335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04781335 about?
NCT04781335 is a clinical study titled ""A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"". Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corne...
What is the current status of trial NCT04781335?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2020-02-20. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT04781335?
The interventions under investigation include: Dexycu (DRUG), Standard of Care post operative eye drops (steroid, antibiotic, NSAID) (DRUG).
Who is sponsoring clinical trial NCT04781335?
This trial is sponsored by The Eye Institute of West Florida, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04781335's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 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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