Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT00198523 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
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 |
What the finished NCT00198523 record still lists
NCT00198523 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisolone is the first listed.
NCT00198523 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00198523's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia