A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Eye Infections Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Prednisolone and Tobramycin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Interventions

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Prednisolone and Tobramycin

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Other Intervention Names

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Pred Forte

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No