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

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ClinicalTrials.gov Identifier: NCT00699803
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : May 1, 2014
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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
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




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


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

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 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.

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00699803     History of Changes
Other Study ID Numbers: CL-PKT-0312081-P
First Posted: June 18, 2008    Key Record Dates
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