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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.

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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

FieldValue
Enrollment Target 132 participants
Start Date 2005-07
Est. Completion 2005-10
Phase Phase 3

Sponsor

Bausch & Lomb Incorporated

174 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.