Back to resultsA Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Primary Purpose
Eye Infections, Postoperative Complications
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prednisolone and Tobramycin
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Eye Infections focused on measuring Cataract Extraction, Anti-Bacterial Agents, Steroids
Eligibility 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
Sites / Locations
- Donald E. Beahm, MD
- Cornea Consultants/Laser Eye Consultants of Boston
- Great Lakes Eye Care
- Eyesight Ophthalmic Services, PA
- Texan Eye Care PA
- Houston Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prednisolone and Tobramycin
Prednisolone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
Secondary Outcome Measures
Full Information
NCT ID
NCT00198523
First Posted
September 13, 2005
Last Updated
March 13, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00198523
Brief Title
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections, Postoperative Complications
Keywords
Cataract Extraction, Anti-Bacterial Agents, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (false)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone and Tobramycin
Arm Type
Experimental
Arm Description
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.
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Prednisolone and Tobramycin
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Pred Forte
Primary Outcome Measure Information:
Title
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Description
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Donald E. Beahm, MD
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Cornea Consultants/Laser Eye Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Great Lakes Eye Care
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Eyesight Ophthalmic Services, PA
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Texan Eye Care PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
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