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

Sponsor:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00699803

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 II

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

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: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	May 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: T-PRED(TM) at the first time point sterile ophthalmic solution
2: Active Comparator	Drug: T-PRED(TM) at the second time point sterile ophthalmic solution
3: Experimental	Drug: Pred Forte(R) at the first time point sterile ophthalmic solution
4: Experimental	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

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-0312081-P
Study First Received:	June 16, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00699803 History of Changes
Health Authority:	United States: Food and Drug Administration

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 March 18, 2010