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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.
Information provided by (Responsible Party):
InSite Vision Identifier:
First received: August 26, 2010
Last updated: June 2, 2016
Last verified: June 2016
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 Intervention Phase
Ocular Inflammation
Drug: ISV-303
Drug: DuraSite Vehicle
Drug: Xibrom™
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • 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.

Enrollment: 169
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: InSite Vision Identifier: NCT01190878     History of Changes
Other Study ID Numbers: C-10-303-001
Study First Received: August 26, 2010
Results First Received: April 26, 2016
Last Updated: June 2, 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 processed this record on April 28, 2017