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NCT04396990 · ClinicalTrials.gov registry record · Phase 4
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
A Phase 4 study, sponsored by Vance Thompson Vision.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04396990: Completed Phase 4 study, sponsored by Vance Thompson Vision.
NCT04396990 is a Phase 4 study that has completed, run by Vance Thompson Vision. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04396990, a Phase 4 study, has completed, sponsored by Vance Thompson Vision.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
Primary Outcome
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
Interventions
- DRUG Topical Prednisolone
- DRUG Dextenza 0.4Mg Ophthalmic Insert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 4 |
What the finished NCT04396990 record still lists
NCT04396990 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 0 conditions, and to 2 interventions - of which Topical Prednisolone is the first listed.
NCT04396990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04396990 about?
NCT04396990 is a clinical study titled "The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study". To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
What is the current status of trial NCT04396990?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-06-08. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT04396990?
The interventions under investigation include: Topical Prednisolone (DRUG), Dextenza 0.4Mg Ophthalmic Insert (DRUG).
Who is sponsoring clinical trial NCT04396990?
This trial is sponsored by Vance Thompson Vision, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04396990'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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