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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
First received: September 28, 2010
Last updated: December 4, 2013
Last verified: December 2013

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:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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.
  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: December 4, 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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014