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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212471
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : December 30, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sign and symptom measures of dry eye disease [ Time Frame: 42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212471

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT01212471     History of Changes
Other Study ID Numbers: S00007
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Bausch & Lomb Incorporated:
Sign and symptoms of dry eye disease

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents