A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
This study has been completed.
Sponsor:
Bausch & Lomb, Inc.
Information provided by (Responsible Party):
Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:
NCT00198523
First received: September 13, 2005
Last updated: March 23, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to demonstrate the bioequivalence of prednisolone acetate in the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension.
Condition | Intervention | Phase |
---|---|---|
Eye Infections Postoperative Complications |
Drug: Prednisolone Acetate 1.0%/Tobramycin 0.3%; PredForte 1.0% |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Eye Infections
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone Sodium Phosphate
Prednisolone phosphate
Methylprednisolone Sodium Succinate
Tobramycin
Tobramycin sulfate
U.S. FDA Resources
Further study details as provided by Bausch & Lomb, Inc.:
Primary Outcome Measures:
- Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Estimated Enrollment: | 132 |
Study Start Date: | July 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198523
Locations
United States, Kansas | |
Donald E. Beahm, MD | |
Great Bend, Kansas, United States, 67530 | |
United States, Massachusetts | |
Cornea Consultants/Laser Eye Consultants of Boston | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Great Lakes Eye Care | |
St. Joseph, Michigan, United States, 49085 | |
United States, New Hampshire | |
Eyesight Ophthalmic Services, PA | |
Portsmouth, New Hampshire, United States, 03801 | |
United States, Texas | |
Texan Eye Care PA | |
Austin, Texas, United States, 78705 | |
Houston Eye Associates | |
Houston, Texas, United States, 77025 |
Sponsors and Collaborators
Bausch & Lomb, Inc.
Investigators
Study Director: | Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. |
More Information
No publications provided
Keywords provided by Bausch & Lomb, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00198523 History of Changes |
Other Study ID Numbers: | ISTA-TP-CPK01 |
Study First Received: | September 13, 2005 |
Last Updated: | March 23, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bausch & Lomb, Inc.:
Cataract Extraction Anti-Bacterial Agents Steroids |
Additional relevant MeSH terms:
Eye Infections Postoperative Complications Infection Eye Diseases Pathologic Processes Tobramycin Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents |
ClinicalTrials.gov processed this record on October 16, 2012