A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01212471

First received: September 28, 2010

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Purpose

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Condition	Intervention	Phase
Dry Eye Syndrome	Drug: Bromfenac Ophthalmic Solution A Drug: Bromfenac Ophthalmic Solution B Drug: Placebo Comparator	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

MedlinePlus related topics: Eye Diseases

Drug Information available for: Bromfenac sodium Bromfenac

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Sign and symptom measures of dry eye disease [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment:	840
Study Start Date:	September 2010
Study Completion Date:	December 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bromfenac Ophthalmic Solution A Bromfenac ophthalmic solution A	Drug: Bromfenac Ophthalmic Solution A sterile ophthalmic solution
Experimental: Bromfenac Ophthalmic Solution B Bromfenac ophthalmic solution B	Drug: Bromfenac Ophthalmic Solution B sterile ophthalmic solution
Placebo Comparator: Placebo Comparator 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:

Be of either gender and any race 18 years or older

Exclusion Criteria:

Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212471

Locations

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01212471 History of Changes
Other Study ID Numbers:	S00007
Study First Received:	September 28, 2010
Last Updated:	March 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:

Sign and symptoms of dry eye disease

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013

To Top