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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: June 16, 2008
Last updated: April 4, 2014
Last verified: April 2014
Study of T-PRED(TM) compared to Pred Forte(R)

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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


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

Exclusion Criteria:

  • No active or adverse disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00699803

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.
  More Information

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00699803     History of Changes
Other Study ID Numbers: CL-PKT-0312081-P
Study First Received: June 16, 2008
Last Updated: April 4, 2014

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Ophthalmic Solutions
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Pharmaceutical Solutions processed this record on May 24, 2017