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NCT01591161 · 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 of Inflammation and Surgery, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
- 1
- Study location
NCT01591161: Completed Phase 3 study of Inflammation and Surgery, sponsored by Bausch & Lomb Incorporated.
NCT01591161 is a Phase 3 study of Inflammation and Surgery that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 369 participants, above the 285-participant average among 132 other Inflammation trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591161, a Phase 3 study of Inflammation and Surgery, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
- 1
- Study location
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.
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mapracorat
Study Locations (1)
New York
- Bausch & Lomb Incorporated - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01591161 record still lists
NCT01591161 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, above the 285-participant average among 132 other Inflammation trials with a reported enrollment target (29% higher).
The record links to 3 conditions, with Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01591161 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01591161 about?
NCT01591161 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.
What is the current status of trial NCT01591161?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2012-07. Estimated completion is 2013-07.
What conditions does trial NCT01591161 study?
This clinical trial studies the following conditions: Inflammation, Surgery, Cataract.
What interventions are being tested in trial NCT01591161?
The interventions under investigation include: Placebo (DRUG), Mapracorat (DRUG).
Who is sponsoring clinical trial NCT01591161?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01591161 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01591161's enrollment target sits among peer trials
369 13th of 132 higher than 120 of 132 other Inflammation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammation 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.
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