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A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date March 15, 2013
Study Start Date  ICMJE July 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)		 Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Eye Infections
  • Postoperative Complications
Intervention  ICMJE
  • Drug: Prednisolone and Tobramycin
  • Drug: Prednisolone
    Other Name: Pred Forte
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Prednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)		 132
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198523
Other Study ID Numbers  ICMJE ISTA-TP-CPK01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bausch & Lomb Incorporated
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bausch & Lomb Incorporated
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
PRS Account Bausch & Lomb Incorporated
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP