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NCT04413253 · ClinicalTrials.gov registry record · Phase 4
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
A Phase 4 study, sponsored by Eye Surgeons of Indiana.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT04413253: Clinical Trial Phase 4 study, sponsored by Eye Surgeons of Indiana.
NCT04413253 is a Phase 4 study that was terminated before completion, run by Eye Surgeons of Indiana. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413253, a Phase 4 study, was terminated before completion, sponsored by Eye Surgeons of Indiana.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
Primary Outcome
As measured by sodium fluorescein and lissamine green
Interventions
- DRUG Lifitegrast 5% Ophthalmic Solution
- DRUG Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-04-11 |
| Phase | Phase 4 |
Why NCT04413253 stopped before completion
NCT04413253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Lifitegrast 5% Ophthalmic Solution is the first listed.
NCT04413253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04413253 about?
NCT04413253 is a clinical study titled "Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease". To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
What is the current status of trial NCT04413253?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2020-08-01. Estimated completion is 2022-04-11.
What interventions are being tested in trial NCT04413253?
The interventions under investigation include: Lifitegrast 5% Ophthalmic Solution (DRUG), Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT04413253?
This trial is sponsored by Eye Surgeons of Indiana, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04413253's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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