A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Postoperative Complications; Eye Infections

Treatments: Drug: Prednisolone and Tobramycin; Drug: Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198523

ISTA-TP-CPK01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Prednisolone and Tobramycin

Experimental group

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.

Treatment:

Drug: Prednisolone and Tobramycin

Prednisolone

Active Comparator group

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.

Treatment:

Drug: Prednisolone