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NCT04498468 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
A Phase 4 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 77
- Enrollment target
NCT04498468: Clinical Trial Phase 4 study, sponsored by Johns Hopkins University.
NCT04498468 is a Phase 4 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 77 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04498468, a Phase 4 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 77 participants
- Enrollment target
Study Summary
To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.
Primary Outcome
OSS will be graded according to the Sjögren's International Collaborative Clinical Alliance (SICCA) grading system. Maximum possible fluorescein score (the punctate epithelial erosions grade + any extra points for modifiers \[central staining, confluent staining, and filaments\]) will be 6 and minimum of 0. Maximum possible conjunctival staining score (the punctate epithelial erosions grade on the temporal and nasal sides) will be 6 and minimum of 0. The total possible maximum OSS, derived by su
Interventions
- DRUG Sustained Release Dexamethasone, 0.4 mg
- OTHER E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2023-03-03 |
| Phase | Phase 4 |
Why NCT04498468 stopped before completion
NCT04498468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Sustained Release Dexamethasone, 0.4 mg is the first listed.
NCT04498468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04498468 about?
NCT04498468 is a clinical study titled "Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye". To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.
What is the current status of trial NCT04498468?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 77 participants. The study started on 2021-03-16. Estimated completion is 2023-03-03.
What interventions are being tested in trial NCT04498468?
The interventions under investigation include: Sustained Release Dexamethasone, 0.4 mg (DRUG), E-Caprolactone-L-Lactide copolymer (PCL) punctal plug (OTHER).
Who is sponsoring clinical trial NCT04498468?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04498468's enrollment target sits among peer trials
77 989th of 2000 higher than 1,007 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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