Status:
COMPLETED
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Eye Infections
Postoperative Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ac...
Eligibility Criteria
Inclusion
- Bilateral cataract surgery
- Avoid disallowed medications throughout study
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00198523
Start Date
July 1 2005
End Date
October 1 2005
Last Update
March 15 2013
Active Locations (6)
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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
Saint Joseph, Michigan, United States, 49085
4
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, United States, 03801