A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00198523

Collaborator

(none)

132

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Infections Postoperative Complications	Drug: Prednisolone and Tobramycin Drug: Prednisolone	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Prednisolone and Tobramycin
Active Comparator: 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.	Drug: Prednisolone Other Names: Pred Forte

Arm

Intervention/Treatment

Experimental: 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.

Drug: Prednisolone and Tobramycin

Active Comparator: 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.

Drug: Prednisolone

Other Names:

Pred Forte

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Donald E. Beahm, MD	Great Bend	Kansas	United States	67530
2	Cornea Consultants/Laser Eye Consultants of Boston	Boston	Massachusetts	United States	02114
3	Great Lakes Eye Care	St. Joseph	Michigan	United States	49085
4	Eyesight Ophthalmic Services, PA	Portsmouth	New Hampshire	United States	03801
5	Texan Eye Care PA	Austin	Texas	United States	78705
6	Houston Eye Associates	Houston	Texas	United States	77025