Efficacy and Safety of Bromfenac Ophthalmic Solution - Full Text View

Efficacy and Safety of Bromfenac Ophthalmic Solution

This study is currently recruiting participants.
Verified by ISTA Pharmaceuticals, December 2007

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00585975

Purpose

This is a safety and efficacy study of bromfenac ophthalmic solution

Condition	Intervention	Phase
Cataract Surgery	Drug: bromfenac ophthalmic solution	Phase II

MedlinePlus related topics:

Cataract

Drug Information available for:

Bromfenac Bromfenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

Cleared post-operative ocular inflammation [ Time Frame: Day 1 & Day 15 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	October 2007
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: bromfenac ophthalmic solution sterile opthalmic solution
2: Experimental	Drug: bromfenac ophthalmic solution sterile opthalmic solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria:

Active corneal pathology in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585975

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: Tim McNamara, PharmD 949-788-6000 tmcnamara@istavision.com

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators


Study Director:	Tim McNamara, PharmD	ISTA Pharmaceuticals, Inc.

More Information

Responsible Party:	ISTA Pharmaceuticals, Inc. ( Tim McNamara, Vice President Clinical Research & Medical Affairs )
Study ID Numbers:	CL-S&E-0802071-P
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00585975
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bromfenac

Eye Diseases

Cataract

Lens Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008