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NCT01124045 · ClinicalTrials.gov registry record · Phase 3
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
A Phase 3 study, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT01124045: Completed Phase 3 study, sponsored by Alcon Research.
NCT01124045 is a Phase 3 study that has completed, run by Alcon Research. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124045, a Phase 3 study, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Primary Outcome
Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflamma
Interventions
- DRUG Difluprednate ophthalmic emulsion, 0.05%
- DRUG Prednisolone acetate ophthalmic suspension, 1.0%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01124045 record still lists
NCT01124045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Difluprednate ophthalmic emulsion, 0.05% is the first listed.
NCT01124045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01124045 about?
NCT01124045 is a clinical study titled "Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery". The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
What is the current status of trial NCT01124045?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2010-08. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01124045?
The interventions under investigation include: Difluprednate ophthalmic emulsion, 0.05% (DRUG), Prednisolone acetate ophthalmic suspension, 1.0% (DRUG).
Who is sponsoring clinical trial NCT01124045?
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 NCT01124045's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 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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