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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699803
First Posted: June 18, 2008
Last Update Posted: May 1, 2014
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
Study of T-PRED(TM) compared to Pred Forte(R)

Condition Intervention Phase
Cataract Drug: T-PRED Drug: Pred Forte Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ratio of means aqueous humor prednisolone acetate concentrations [ Time Frame: 2 weeks ]

Enrollment: 56
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: T-Pred
Tobramycin prednisolone acetate combination
Drug: T-PRED
sterile ophthalmic solution at the first time point
Drug: Pred Forte
sterile ophthalmic solution at the first time point
Active Comparator: Pred Forte
Prednisolone acetate
Drug: T-PRED
sterile ophthalmic solution at the second time point
Drug: Pred Forte
sterile ophthalmic solution at the second time point

  Eligibility

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
Criteria

Inclusion Criteria:

  • 18 years of age

Exclusion Criteria:

  • No active or adverse disease
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00699803


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00699803     History of Changes
Other Study ID Numbers: CL-PKT-0312081-P
First Submitted: June 16, 2008
First Posted: June 18, 2008
Last Update Posted: May 1, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Pharmaceutical Solutions
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
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents