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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

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ClinicalTrials.gov Identifier: NCT01190878
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
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
U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InSite Vision
ClinicalTrials.gov 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:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents