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

This study has been completed.

First Received on February 26, 2009. Last Updated on September 9, 2011 History of Changes

Sponsor:	ISTA Pharmaceuticals
Information provided by (Responsible Party):	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00854061

Purpose

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

Condition	Intervention	Phase
Cataract	Drug: T-Pred(TM) Ophthalmic Solution Drug: Pred Forte(R)	Phase III

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:

MedlinePlus related topics: Cataract

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate 16-Methyleneprednisolone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by ISTA Pharmaceuticals:

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
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: T-Pred(TM) Ophthalmic Solution sterile ophthalmic solution
Active Comparator: 2	Drug: Pred Forte(R) 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

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

ISTA Pharmaceuticals

Investigators

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00854061 History of Changes
Other Study ID Numbers:	CL-PKT-0415083-P
Study First Received:	February 26, 2009
Last Updated:	September 9, 2011
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 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 February 09, 2012