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NCT01230125 · ClinicalTrials.gov registry record · Phase 3
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
A Phase 3 study of Cataract, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 311
- Enrollment target
- 1
- Study location
NCT01230125: Completed Phase 3 study of Cataract, sponsored by Bausch & Lomb Incorporated.
NCT01230125 is a Phase 3 study of Cataract that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 311 participants, above the 225-participant average among 83 other Cataract trials with a reported enrollment target (38% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230125, a Phase 3 study of Cataract, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 311 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% to 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 Vehicle
- DRUG Mapracorat
Study Locations (1)
New York
- Bausch & Lomb, Incorporated - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01230125 record still lists
NCT01230125 is an interventional study that assigns participants to a tested intervention. The registered 311 participants enrollment target is mid-sized for trials with a published cap, above the 225-participant average among 83 other Cataract trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT01230125 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01230125 about?
NCT01230125 is a clinical study titled "Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery". The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
What is the current status of trial NCT01230125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 311 participants. The study started on 2010-11. Estimated completion is 2011-08.
What conditions does trial NCT01230125 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT01230125?
The interventions under investigation include: Vehicle (DRUG), Mapracorat (DRUG).
Who is sponsoring clinical trial NCT01230125?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01230125 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
Similar trials for Cataract
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01230125's enrollment target sits among peer trials
311 17th of 83 higher than 67 of 83 other Cataract trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cataract 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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