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A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

NCT00198523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2013-03-15

No results posted yet for this 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.

Conditions

  • Eye Infections
  • Postoperative Complications

Interventions

DRUG

Prednisolone and Tobramycin

DRUG

Prednisolone

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Tim McNamara, PharmD · ISTA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2005-10-31
Completion
2005-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198523 on ClinicalTrials.gov