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

This study has been completed.
Information provided by (Responsible Party):
InSite Vision Identifier:
First received: April 10, 2012
Last updated: June 2, 2016
Last verified: June 2016
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
Ocular Inflammation
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: Treatment
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:
  • Ocular Inflammation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications.

Enrollment: 268
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-303
0.075% bromfenac in DuraSite vehicle dosed BID
Drug: ISV-303
Bromfenac in DuraSite
Placebo Comparator: DuraSite Vehicle
DuraSite Vehicle dosed BID
Other: DuraSite Vehicle
DuraSite Vehicle


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

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 (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.

No Contacts or Locations Provided
  More Information

Responsible Party: InSite Vision Identifier: NCT01576952     History of Changes
Other Study ID Numbers: C-11-303-003 
Study First Received: April 10, 2012
Results First Received: April 26, 2016
Last Updated: June 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases processed this record on October 27, 2016