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

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: NCT00699803
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : September 3, 2020
Last Update Posted : September 25, 2020
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 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : May 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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

Active Comparator: Pred Forte
Prednisolone acetate
Drug: Pred Forte
Pred Forte sterile ophthalmic solution

Primary Outcome Measures :
  1. Mean Aqueous Humor Prednisolone Acetate Concentration [ Time Frame: 4 hours ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 years of age

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): NCT00699803

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United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00699803    
Other Study ID Numbers: CL-PKT-0312081-P
First Posted: June 18, 2008    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 25, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
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