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

This study is currently recruiting participants.

Verified by ISTA Pharmaceuticals, February 2009

First Received: February 26, 2009 No Changes Posted

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment

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 ]

Estimated Enrollment:	150
Study Start Date:	February 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Tim McNamara, PharmD

949-788-6000

tmcnamara@istavision.com

Locations

United States, California
ISTA Pharmaceuticals, Inc.	Recruiting
Irvine, California, United States, 92618
Contact: Sharon Klier, MD, MPH 949-788-6000 sklier@istavision.com

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	ISTA Pharmaceuticals, Inc. ( Tim McNamara, Vice President Clinical Research & Medical Affairs )
Study ID Numbers:	CL-PKT-0415083-P
Study First Received:	February 26, 2009
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00854061 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Methylprednisolone acetate
Antiemetics
Lens Diseases

Prednisolone acetate
Hormones
Neuroprotective Agents
Glucocorticoids
Cataract
Prednisolone
Peripheral Nervous System Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Methylprednisolone
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Methylprednisolone acetate
Antiemetics
Lens Diseases
Prednisolone acetate

Hormones
Glucocorticoids
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Autonomic Agents
Cataract
Therapeutic Uses
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on September 11, 2009