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NCT04380857 · ClinicalTrials.gov registry record · Phase 4
Assessing Dextenza Insert After SMILE Procedure
A Phase 4 study of Post Procedural Infection, sponsored by William Wiley, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04380857: Completed Phase 4 study of Post Procedural Infection, sponsored by William Wiley, MD.
NCT04380857 is a Phase 4 study of Post Procedural Infection that has completed, run by William Wiley, MD. 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
NCT04380857, a Phase 4 study of Post Procedural Infection, has completed, sponsored by William Wiley, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
Primary Outcome
post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)
Conditions Studied
Interventions
- DRUG Dexamethasone ophthalmic insert 0.4 mg
- DRUG Topical Prednisolone Acetate Ophthalmic Drops
Study Locations (1)
Ohio
- Cleveland Eye Clinic - Brecksville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 4 |
What the finished NCT04380857 record still lists
NCT04380857 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 1 condition, with Post Procedural Infection appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone ophthalmic insert 0.4 mg is the first listed.
NCT04380857 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04380857 about?
NCT04380857 is a clinical study titled "Assessing Dextenza Insert After SMILE Procedure". This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, t...
What is the current status of trial NCT04380857?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-06-18. Estimated completion is 2021-06-21.
What conditions does trial NCT04380857 study?
This clinical trial studies the following conditions: Post Procedural Infection.
What interventions are being tested in trial NCT04380857?
The interventions under investigation include: Dexamethasone ophthalmic insert 0.4 mg (DRUG), Topical Prednisolone Acetate Ophthalmic Drops (DRUG).
Who is sponsoring clinical trial NCT04380857?
This trial is sponsored by William Wiley, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04380857 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04380857's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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