A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tobramycin

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