Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01576952
First received: April 10, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.


Condition Intervention Phase
Cataract
Drug: ISV-303
Other: DuraSite Vehicle
Phase 3

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 Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

Resource links provided by NLM:


Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • post-surgical ocular inflammation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-surgical ocular pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-303 Drug: ISV-303
Bromfenac in DuraSite
Placebo Comparator: DuraSite Vehicle Other: DuraSite Vehicle
DuraSite Vehicle

  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 with posterior chamber intraocular lens implantation
  • If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. 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 to avoid disallowed medication for the duration of the study.
  • 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)
  • Additional inclusion criteria also apply

Exclusion Criteria:

  • Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
  • Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive 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
  • Additional exclusion criteria also apply
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576952

Locations
United States, Arizona
Cornea Consultants of Arizona
Phoenix, Arizona, United States, 85032
United States, California
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States, 91345
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
United States, Florida
Hernando Eye Institute
Brooksville, Florida, United States, 34613
International Research Center
Tampa, Florida, United States, 33603
United States, Louisiana
Lakeview Optical
Gretna, Louisiana, United States, 70056
United States, Michigan
Great Lakes Eye Care
St. Joseph, Michigan, United States, 49085
United States, Missouri
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
United States, New York
South Shore Eye Care, LLP
Wantagh, New York, United States, 11793
United States, North Carolina
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, United States, 28210
Cornerstone Eye Care
High Point, North Carolina, United States, 27262
United States, Ohio
Eye Care Associates of Greater Cincinnati, Inc
Cincinnati, Ohio, United States, 45238
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
United States, Texas
Texan Eye, PA
Austin, Texas, United States, 78731
Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01576952     History of Changes
Other Study ID Numbers: C-11-303-003
Study First Received: April 10, 2012
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSite Vision:
ISV-303
cataract
DuraSite

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 July 22, 2014