Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

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. Identifier: NCT01190878
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):
InSite Vision

Brief Summary:
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

Condition or disease Intervention/treatment Phase
Ocular Inflammation Drug: ISV-303 Drug: DuraSite Vehicle Drug: Xibrom™ Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: ISV-303 BID Drug: ISV-303
0.075% of bromfenac in DuraSite dosed BID

Experimental: ISV-303 QD Drug: ISV-303
0.075% of bromfenac in DuraSite dosed QD

Active Comparator: Xibrom BID Drug: Xibrom™
0.09% bromfenac dosed BID

Placebo Comparator: DuraSite Vehicle BID Drug: DuraSite Vehicle
Vehicle dosed BID

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: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
  • Meet the best corrected visual acuity score requirement
  • Meet the IOP requirement
  • 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
  • Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
  • Additional exclusion criteria also apply

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: InSite Vision Identifier: NCT01190878     History of Changes
Other Study ID Numbers: C-10-303-001
First Posted: August 30, 2010    Key Record Dates
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents