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:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01190878
First received: August 26, 2010
Last updated: September 17, 2013
Last verified: September 2013

August 26, 2010
September 17, 2013
August 2010
January 2011   (final data collection date for primary outcome measure)
post-surgical ocular inflammation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01190878 on ClinicalTrials.gov Archive Site
post-surgical ocular pain [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ocular Inflammation
  • Pain
  • Cataract
  • Drug: ISV-303
    % of Bromfenac in DuraSite Dosed QD
  • Drug: ISV-303
    % of Bromfenac in DuraSite Dosed BID
  • Drug: DuraSite Vehicle
    Vehicle Dosed BID
  • Drug: Xibrom™
    Xibrom 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01190878
C-10-303-001
No
InSite Vision
InSite Vision
Not Provided
Not Provided
InSite Vision
September 2013

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