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A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eye Infections; Postoperative Complications

Intervention: Prednisolone and Tobramycin (Drug); Prednisolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Tim McNamara, PharmD, Study Director, Affiliation: ISTA Pharmaceuticals, Inc.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Donald E. Beahm, MD, Great Bend, Kansas 67530, United States

Cornea Consultants/Laser Eye Consultants of Boston, Boston, Massachusetts 02114, United States

Great Lakes Eye Care, St. Joseph, Michigan 49085, United States

Eyesight Ophthalmic Services, PA, Portsmouth, New Hampshire 03801, United States

Texan Eye Care PA, Austin, Texas 78705, United States

Houston Eye Associates, Houston, Texas 77025, United States

Additional Information

Starting date: July 2005
Last updated: March 13, 2013

Page last updated: August 23, 2015

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