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NCT00198523 · ClinicalTrials.gov registry record · Phase 3
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT00198523 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 132 participants.
The verdict
NCT00198523, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
Interventions
- DRUG Prednisolone
- DRUG Prednisolone and Tobramycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2005-07 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00198523
The ClinicalTrials.gov registry entry for NCT00198523 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prednisolone is the first listed.
NCT00198523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00198523 about?
NCT00198523 is a clinical study titled "A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte". The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concen...
What is the current status of trial NCT00198523?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2005-07. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00198523?
The interventions under investigation include: Prednisolone (DRUG), Prednisolone and Tobramycin (DRUG).
Who is sponsoring clinical trial NCT00198523?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
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