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NCT00924729 · ClinicalTrials.gov registry record · Phase 4
Study of Ocular Penetration of Topically Administered Fluoroquinolones
A Phase 4 study of Cataract Extraction, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00924729: Completed Phase 4 study of Cataract Extraction, sponsored by Johns Hopkins University.
NCT00924729 is a Phase 4 study of Cataract Extraction that has completed, run by Johns Hopkins University. The registered enrollment target is 50 participants, below the 94-participant average among 4 other Cataract Extraction trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924729, a Phase 4 study of Cataract Extraction, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.
Primary Outcome
Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chrom
Conditions Studied
Interventions
- DRUG Moxifloxacin 0.5% ophthalmic solution
- DRUG Besifloxacin 0.6% ophthalmic suspension
Study Locations (1)
Maryland
- The Wilmer Eye Institute at Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
What the finished NCT00924729 record still lists
NCT00924729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 94-participant average among 4 other Cataract Extraction trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Cataract Extraction appearing as the primary indexed condition, and to 2 interventions - of which Moxifloxacin 0.5% ophthalmic solution is the first listed.
NCT00924729 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00924729 about?
NCT00924729 is a clinical study titled "Study of Ocular Penetration of Topically Administered Fluoroquinolones". This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.
What is the current status of trial NCT00924729?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2009-09. Estimated completion is 2009-11.
What conditions does trial NCT00924729 study?
This clinical trial studies the following conditions: Cataract Extraction.
What interventions are being tested in trial NCT00924729?
The interventions under investigation include: Moxifloxacin 0.5% ophthalmic solution (DRUG), Besifloxacin 0.6% ophthalmic suspension (DRUG).
Who is sponsoring clinical trial NCT00924729?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00924729 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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