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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00854061
First received: February 26, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Cataract
Drug: T-Pred
Drug: Pred Forte
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older

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 ClinicalTrials.gov identifier: NCT00854061

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00854061     History of Changes
Other Study ID Numbers: CL-PKT-0415083-P
Study First Received: February 26, 2009
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014