Study of T-PRED(TM) Compared to Pred Forte(R) II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854061
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 1, 2014
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
Study of T-PRED(TM) Compared to Pred Forte(R)

Condition or disease Intervention/treatment Phase
Cataract Drug: T-Pred Drug: Pred Forte Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : February 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: T-Pred
Tobramycin prednisolone acetate combination
Drug: T-Pred
sterile ophthalmic solution
Active Comparator: Pred Forte
Prednisolone acetate
Drug: Pred Forte
sterile ophthalmic solution

Primary Outcome Measures :
  1. Ratio of means aqueous humor prednisolone acetate concentrations [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

  • No active or adverse disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00854061

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00854061     History of Changes
Other Study ID Numbers: CL-PKT-0415083-P
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Pharmaceutical Solutions
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents