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:
InSite Vision
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01190878
First received: August 26, 2010
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
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 Pain Cataract |
Drug: ISV-303 Drug: DuraSite Vehicle Drug: Xibrom™ |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
- post-surgical ocular inflammation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- post-surgical ocular pain [ Time Frame: 15 days ] [ Designated as safety issue: No ]
| 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
% of Bromfenac in DuraSite Dosed BID
|
| Experimental: ISV-303 QD |
Drug: ISV-303
% of Bromfenac in DuraSite Dosed QD
|
| Active Comparator: Xibrom BID |
Drug: Xibrom™
Xibrom dosed BID
|
| Placebo Comparator: DuraSite Vehicle BID |
Drug: DuraSite Vehicle
Vehicle Dosed BID
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190878
Locations
| United States, Florida | |
| Hernando Eye Institute | |
| Brooksville, Florida, United States | |
| Center for Excellence in Eye Care | |
| Miami, Florida, United States | |
| United States, Louisiana | |
| Daniel Long | |
| Gretna, Louisiana, United States | |
| United States, Michigan | |
| Great Lakes Eye Care | |
| St. Joseph, Michigan, United States | |
| United States, Missouri | |
| Silverstein Eye Centers | |
| Kansas City, Missouri, United States | |
| Comprehensive Eye Care | |
| Washington, Missouri, United States | |
| United States, North Carolina | |
| Charlotte Eye, Ear, Nose, and Throat | |
| Charlotte, North Carolina, United States | |
| United States, Tennessee | |
| Chattanooga Eye Institute | |
| Chattanooga, Tennessee, United States | |
| United States, Texas | |
| Texan Eye Care | |
| Austin, Texas, United States | |
| Houston Eye Associates | |
| Houston, Texas, United States | |
Sponsors and Collaborators
InSite Vision
More Information
No publications provided
| Responsible Party: | InSite Vision |
| ClinicalTrials.gov Identifier: | NCT01190878 History of Changes |
| Other Study ID Numbers: | C-10-303-001 |
| Study First Received: | August 26, 2010 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by InSite Vision:
|
cataract bromfenac xibrom durasite |
ocular inflammation ocular pain post surgical post cataract surgery ocular inflammation and pain |
Additional relevant MeSH terms:
|
Cataract Inflammation 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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013