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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190878
First Posted: August 30, 2010
Last Update Posted: July 13, 2016
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.
Information provided by (Responsible Party):
InSite Vision
August 26, 2010
August 30, 2010
April 26, 2016
July 13, 2016
July 13, 2016
August 2010
January 2011   (Final data collection date for primary outcome measure)
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.
post-surgical ocular inflammation [ Time Frame: 15 days ]
Complete list of historical versions of study NCT01190878 on ClinicalTrials.gov Archive Site
Not Provided
post-surgical ocular pain [ Time Frame: 15 days ]
Not Provided
Not Provided
 
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ocular Inflammation
  • Drug: ISV-303
    0.075% of bromfenac in DuraSite dosed QD
  • Drug: ISV-303
    0.075% of bromfenac in DuraSite dosed BID
  • Drug: DuraSite Vehicle
    Vehicle dosed BID
  • Drug: Xibrom™
    0.09% bromfenac dosed BID
  • Experimental: ISV-303 BID
    Intervention: Drug: ISV-303
  • Experimental: ISV-303 QD
    Intervention: Drug: ISV-303
  • Active Comparator: Xibrom BID
    Intervention: Drug: Xibrom™
  • Placebo Comparator: DuraSite Vehicle BID
    Intervention: Drug: DuraSite Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01190878
C-10-303-001
No
Not Provided
Not Provided
InSite Vision
InSite Vision
Not Provided
Not Provided
InSite Vision
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP