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NCT01001806 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
A Phase 4 study of Cataracts, sponsored by Frank A. Bucci, Jr., M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT01001806 is a Phase 4 study of Cataracts that has completed, run by Frank A. Bucci, Jr., M.D.. The registered enrollment target is 126 participants, above the 82-participant average among 8 other Cataracts trials with a reported enrollment target (54% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01001806, a Phase 4 study of Cataracts, has completed, sponsored by Frank A. Bucci, Jr., M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
Conditions Studied
Interventions
- DRUG nepafenac 0.1%
- DRUG Ketorolac Tromethamine 0.45%
- DRUG bromfenac 0.09%
Study Locations (1)
Pennsylvania
- Bucci Laser Vision Institute - Wilkes-Barre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01001806
The ClinicalTrials.gov registry entry for NCT01001806 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 82-participant average among 8 other Cataracts trials with a reported enrollment target (54% higher). The listed sponsor is Frank A. Bucci, Jr., M.D., which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cataracts appearing as the primary indexed condition, and to 3 interventions - of which nepafenac 0.1% is the first listed.
NCT01001806 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01001806 about?
NCT01001806 is a clinical study titled "A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification". Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue d...
What is the current status of trial NCT01001806?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 126 participants. The study started on 2009-10. Estimated completion is 2010-01.
What conditions does trial NCT01001806 study?
This clinical trial studies the following conditions: Cataracts.
What interventions are being tested in trial NCT01001806?
The interventions under investigation include: nepafenac 0.1% (DRUG), Ketorolac Tromethamine 0.45% (DRUG), bromfenac 0.09% (DRUG).
Who is sponsoring clinical trial NCT01001806?
This trial is sponsored by Frank A. Bucci, Jr., M.D., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01001806 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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