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NCT01591655 · ClinicalTrials.gov registry record · Phase 3
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
NCT01591655: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01591655 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 360 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591655, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
Study Summary
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.
Primary Outcome
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Interventions
- DRUG Vehicle
- DRUG Mapracorat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01591655 record still lists
NCT01591655 is an interventional study that assigns participants to a tested intervention. The registered 360 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 (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01591655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591655 about?
NCT01591655 is a clinical study titled "Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery". The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.
What is the current status of trial NCT01591655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01591655?
The interventions under investigation include: Vehicle (DRUG), Mapracorat (DRUG).
Who is sponsoring clinical trial NCT01591655?
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 NCT01591655's enrollment target sits among peer trials
360 1008th of 2000 higher than 980 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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