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NCT01201798 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
A Phase 3 study, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
NCT01201798: Completed Phase 3 study, sponsored by Alcon Research.
NCT01201798 is a Phase 3 study that has completed, run by Alcon Research. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01201798, a Phase 3 study, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.
Primary Outcome
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
Interventions
- DRUG Difluprednate 0.05% ophthalmic emulsion
- DRUG Prednisolone acetate 1.0% ophthalmic suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01201798 record still lists
NCT01201798 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Difluprednate 0.05% ophthalmic emulsion is the first listed.
NCT01201798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01201798 about?
NCT01201798 is a clinical study titled "Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis". The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.
What is the current status of trial NCT01201798?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2010-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01201798?
The interventions under investigation include: Difluprednate 0.05% ophthalmic emulsion (DRUG), Prednisolone acetate 1.0% ophthalmic suspension (DRUG).
Who is sponsoring clinical trial NCT01201798?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01201798's enrollment target sits among peer trials
111 1655th of 2000 higher than 344 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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