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NCT00198523 Clinical Trial

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198523
Other study ID # ISTA-TP-CPK01
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 13, 2013
Start date July 2005
Est. completion date October 2005

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisolone and Tobramycin

• Prednisolone

Locations
Country Name City State
United States Texan Eye Care PA Austin Texas
United States Cornea Consultants/Laser Eye Consultants of Boston Boston Massachusetts
United States Donald E. Beahm, MD Great Bend Kansas
United States Houston Eye Associates Houston Texas
United States Eyesight Ophthalmic Services, PA Portsmouth New Hampshire
United States Great Lakes Eye Care St. Joseph Michigan

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 days No
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