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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 is a Phase 4 study of Post Procedural Infection that has completed, run by William Wiley, MD. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380857
The ClinicalTrials.gov registry entry for NCT04380857 describes a study currently listed as completed, 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 William Wiley, MD, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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