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Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01387464
First received: June 29, 2011
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.


Condition Intervention Phase
Cataract
 Drug: ISV-303
Drug: Bromday™
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • Anterior chamber paracentesis [ Time Frame: approximately 3 hours post last dose ] [ Designated as safety issue: No ]
    Mean aqueous humor concentrations of bromfenac for the 2 treatment arms will be statistically compared.


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-303 Drug: ISV-303
% of Bromfenac in DuraSite dosed QD
Active Comparator: Bromday™ Drug: Bromday™
Bromday™ (0.09% Bromfenac) dosed QD

  Eligibility

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

Inclusion Criteria:

  • Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
  • If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
  • Signature of the subject on the Informed Consent Form
  • Willing and able to follow all instructions and attend all study visits
  • Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria:

  • Use of any drug containing bromfenac within 2 weeks prior to surgery
  • Contact lens wear during the dosing period
  • Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
  • Any serious complications with or macroscopic damage to the corneal epithelium
  • Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
  • Currently suffer from alcohol and/or drug abuse
  • Prior participation in this study protocol
  • Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
  • A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387464

Locations
United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Louisiana
120 Meadowcrest Street, Suite 330
Gretna, Louisiana, United States, 70056
United States, Texas
Texan Eye Care
Austin, Texas, United States, 78731
Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01387464     History of Changes
Other Study ID Numbers: C-11-303-002
Study First Received: June 29, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by InSite Vision:
bromfenac concentrations
ISV-303
Bromday

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye 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 22, 2013