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