Text Size

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198523
First received: September 13, 2005
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Eye Infections
Postoperative Complications
 Drug: Prednisolone and Tobramycin
Drug: Prednisolone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Comparison of aqueous humor concentrations of prednisolone acetate at various time points


Estimated Enrollment: 132
Study Start Date: July 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Texan Eye Care PA
Austin, Texas, United States, 78705
Houston Eye Associates
Houston, Texas, United States, 77025
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198523     History of Changes
Other Study ID Numbers: ISTA-TP-CPK01
Study First Received: September 13, 2005
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Cataract Extraction
Anti-Bacterial Agents
Steroids

Additional relevant MeSH terms:
Eye Infections
Postoperative Complications
Infection
Eye Diseases
Pathologic Processes
Tobramycin
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 23, 2013