A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

This study has been completed.

First Received: September 13, 2005 Last Updated: January 15, 2007 History of Changes

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198523

Purpose

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.

Condition	Intervention	Phase
Eye Infections Postoperative Complications	Drug: Prednisolone Acetate 1.0%/Tobramycin 0.3%; PredForte 1.0%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Eye Infections

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Tobramycin Tobramycin sulfate Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	132
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198523

Locations

United States, Kansas
Donald E. Beahm, MD
Great Bend, Kansas, United States, 67530
United States, Massachusetts
Cornea Consultants/Laser Eye Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
Great Lakes Eye Care
St. Joseph, Michigan, United States, 49085
United States, New Hampshire
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, United States, 03801
United States, Texas
Houston Eye Associates
Houston, Texas, United States, 77025
Texan Eye Care PA
Austin, Texas, United States, 78705

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Study ID Numbers:	ISTA-TP-CPK01
Study First Received:	September 13, 2005
Last Updated:	January 15, 2007
ClinicalTrials.gov Identifier:	NCT00198523 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ISTA Pharmaceuticals:

Cataract Extraction
Anti-Bacterial Agents
Steroids

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Tobramycin
Methylprednisolone
Hormone Antagonists
Eye Diseases
Eye Infections
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate

Prednisolone acetate
Neuroprotective Agents
Hormones
Glucocorticoids
Anti-Bacterial Agents
Postoperative Complications
Cataract
Prednisolone
Peripheral Nervous System Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Infection
Neuroprotective Agents
Hormones
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Methylprednisolone Hemisuccinate

Tobramycin
Antineoplastic Agents, Hormonal
Eye Diseases
Eye Infections
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Postoperative Complications
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009