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

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.
ClinicalTrials.gov Identifier: NCT01576952
Recruitment Status : Completed
First Posted : April 13, 2012
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ocular Inflammation Drug: ISV-303 Other: DuraSite Vehicle Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Ocular Inflammation [ Time Frame: 15 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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
More Information

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01576952     History of Changes
Other Study ID Numbers: C-11-303-003
First Posted: April 13, 2012    Key Record Dates
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases