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NCT01475643 · ClinicalTrials.gov registry record · Phase 3
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT01475643: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01475643 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 107 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
NCT01475643, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Primary Outcome
Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D \[g20 Diopter\] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4.
Interventions
- DRUG Loteprednol etabonate
- DRUG Prednisolones acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-07 |
| Phase | Phase 3 |
What the finished NCT01475643 record still lists
NCT01475643 is an interventional study that assigns participants to a tested intervention. The registered 107 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 Loteprednol etabonate is the first listed.
NCT01475643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01475643 about?
NCT01475643 is a clinical study titled "Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.". The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
What is the current status of trial NCT01475643?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2013-06. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01475643?
The interventions under investigation include: Loteprednol etabonate (DRUG), Prednisolones acetate (DRUG).
Who is sponsoring clinical trial NCT01475643?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01475643's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 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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