A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 15, 2007

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00198523 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Official Title ^ICMJE

A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of prednisolone acetate in the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Condition ^ICMJE

Eye Infections
Postoperative Complications

Intervention ^ICMJE

Drug: Prednisolone Acetate 1.0%/Tobramycin 0.3%; PredForte 1.0%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

132

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Bilateral cataract surgery
Avoid disallowed medications throughout study

Exclusion Criteria:

Contraindications to the use of the test agents
Known allergy or sensitivity to the test agents or components
History of steroid response following topical administration of corticosteroids in the eye
Wore contact lenses 48 hours prior to Visit 1
An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
Any significant illness that could be expected to interfere with study
Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00198523

Responsible Party

Study ID Numbers ^ICMJE

ISTA-TP-CPK01

Study Sponsor ^ICMJE

ISTA Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

Information Provided By

ISTA Pharmaceuticals

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP