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A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

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ClinicalTrials.gov Identifier: NCT00198523
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Eye Infections Postoperative Complications Drug: Prednisolone and Tobramycin Drug: Prednisolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Prednisolone and Tobramycin
Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.
 Drug: Prednisolone and Tobramycin
Active Comparator: Prednisolone
Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.
 Drug: Prednisolone
Other Name: Pred Forte


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points [ Time Frame: 2 days ]
    Comparison of aqueous humor concentrations of prednisolone acetate at various time points


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198523


Locations
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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
Texan Eye Care PA
Austin, Texas, United States, 78705
Houston Eye Associates
Houston, Texas, United States, 77025
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198523    
Other Study ID Numbers: ISTA-TP-CPK01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Bausch & Lomb Incorporated:
Cataract Extraction
Anti-Bacterial Agents
Steroids
Additional relevant MeSH terms:
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Eye Infections
Postoperative Complications
Pathologic Processes
Infections
Eye Diseases
Tobramycin
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Bacterial Agents
Anti-Infective Agents