A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Phase 3

Completed

• Conditions: Eye Infections; Postoperative Complications
• Interventions: Drug: Prednisolone and Tobramycin; Drug: Prednisolone

• Registration Number: NCT00198523
• Lead Sponsor: Bausch & Lomb Incorporated

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 available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone and Tobramycin	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.
Prednisolone	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.

Primary Outcome Measures

Name	Time	Method
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points	2 days	Comparison of aqueous humor concentrations of prednisolone acetate at various time points

Trial Locations

Locations (6)

Cornea Consultants/Laser Eye Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Donald E. Beahm, MD; 🇺🇸 Great Bend, Kansas, United States

Great Lakes Eye Care; 🇺🇸 St. Joseph, Michigan, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Eyesight Ophthalmic Services, PA; 🇺🇸 Portsmouth, New Hampshire, United States

Texan Eye Care PA; 🇺🇸 Austin, Texas, United States