Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

This study is currently recruiting participants.

Verified by ISTA Pharmaceuticals, June 2008

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00704418

Purpose

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Condition	Intervention	Phase
Cataract Extraction With Intraocular Lens Implantation	Drug: bromfenac ophthalmic solution Drug: Placebo comparator	Phase III

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, Investigator), Parallel Assignment

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

Ocular inflammation [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
Study Start Date:	June 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: bromfenac ophthalmic solution sterile ophthalmic solution
2: Placebo Comparator	Drug: Placebo comparator sterile ophthalmic solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled for cataract surgery

Exclusion Criteria:

Known hypersensitivity to bromfenac and salicylates

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704418

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: Ralph Bianca, PhD 949-788-6000 rbianca@istavision.com

Sponsors and Collaborators

ISTA Pharmaceuticals

More Information

Responsible Party:	ISTA Pharmaceuticals, Inc. ( Tim McNamara, Vice President Clinical Research & Medical Affairs )
Study ID Numbers:	CL-S&E-0415081-P-WR
Study First Received:	June 20, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00704418
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 January 16, 2009