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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00699803
First received: June 16, 2008
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cataract
 Drug: T-PRED(TM) at the first time point
Drug: T-PRED(TM) at the second time point
Drug: Pred Forte(R) at the first time point
Drug: Pred Forte(R) at the second time point
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ratio of means aqueous humor prednisolone acetate concentrations [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: T-PRED(TM) at the first time point
sterile ophthalmic solution
Active Comparator: 2 Drug: T-PRED(TM) at the second time point
sterile ophthalmic solution
Experimental: 3 Drug: Pred Forte(R) at the first time point
sterile ophthalmic solution
Experimental: 4 Drug: Pred Forte(R) at the second time point
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

Exclusion Criteria:

  • No active or adverse disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00699803     History of Changes
Other Study ID Numbers: CL-PKT-0312081-P
Study First Received: June 16, 2008
Last Updated: January 3, 2013
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
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013