Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
This study is ongoing, but not recruiting participants.
Sponsor:
InSite Vision
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01576952
First received: April 10, 2012
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Drug: ISV-303 Other: DuraSite Vehicle |
Phase 3 |
| 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: Basic Science |
| Official Title: | A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects |
Resource links provided by NLM:
Further study details as provided by InSite Vision:
Primary Outcome Measures:
- post-surgical ocular inflammation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- post-surgical ocular pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ISV-303 |
Drug: ISV-303
Bromfenac in DuraSite
|
| Placebo Comparator: DuraSite Vehicle |
Other: DuraSite Vehicle
DuraSite Vehicle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
- If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
- Signature of the subject on the Informed Consent Form
- Willing to avoid disallowed medication for the duration of the study.
- Willing and able to follow all instructions and attend all study visits
- Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
- 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
- Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- Currently suffer from alcohol and/or drug abuse
- Prior participation in this study protocol
- Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
- A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
- Additional exclusion criteria also apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576952
Locations
| United States, Arizona | |
| Cornea Consultants of Arizona | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| North Valley Eye Medical Group, Inc. | |
| Mission Hills, California, United States, 91345 | |
| North Bay Eye Associates, Inc. | |
| Petaluma, California, United States, 94954 | |
| United States, Florida | |
| Hernando Eye Institute | |
| Brooksville, Florida, United States, 34613 | |
| International Research Center | |
| Tampa, Florida, United States, 33603 | |
| United States, Louisiana | |
| Lakeview Optical | |
| Gretna, Louisiana, United States, 70056 | |
| United States, Michigan | |
| Great Lakes Eye Care | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Silverstein Eye Centers | |
| Kansas City, Missouri, United States, 64133 | |
| Ophthalmology Associates | |
| St. Louis, Missouri, United States, 63131 | |
| United States, New York | |
| South Shore Eye Care, LLP | |
| Wantagh, New York, United States, 11793 | |
| United States, North Carolina | |
| Charlotte Eye Ear Nose and Throat Associates, PA | |
| Charlotte, North Carolina, United States, 28210 | |
| Cornerstone Eye Care | |
| High Point, North Carolina, United States, 27262 | |
| United States, Ohio | |
| Eye Care Associates of Greater Cincinnati, Inc | |
| Cincinnati, Ohio, United States, 45238 | |
| United States, Pennsylvania | |
| Eye Care Specialists | |
| Kingston, Pennsylvania, United States, 18704 | |
| United States, Texas | |
| Texan Eye, PA | |
| Austin, Texas, United States, 78731 | |
Sponsors and Collaborators
InSite Vision
More Information
No publications provided
| Responsible Party: | InSite Vision |
| ClinicalTrials.gov Identifier: | NCT01576952 History of Changes |
| Other Study ID Numbers: | C-11-303-003 |
| Study First Received: | April 10, 2012 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by InSite Vision:
|
ISV-303 cataract DuraSite |
Additional relevant MeSH terms:
|
Cataract 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