A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Completed · Phase 3

Conditions studied: Eye Infections, Postoperative Complications

In brief

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.

Key facts

Study ID

NCT00198523

Run by

Bausch & Lomb Incorporated

People needed

132

Starts

2005-07-01

Expected to finish

2005-10-01

Last updated by the study team

2013-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bilateral cataract surgery
• Avoid disallowed medications throughout study

You may not qualify if…

• 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

Where it is running

• Donald E. Beahm, MD — Great Bend, Kansas, United States
• Cornea Consultants/Laser Eye Consultants of Boston — Boston, Massachusetts, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• Eyesight Ophthalmic Services, PA — Portsmouth, New Hampshire, United States
• Texan Eye Care PA — Austin, Texas, United States
• Houston Eye Associates — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.