Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis (DOUBle)
This study is ongoing, but not recruiting participants.
Sponsor:
InSite Vision
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01408082
First received: August 1, 2011
Last updated: September 13, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Blepharitis |
Drug: ISV-502 Drug: Azasite Drug: Dexamethasone Other: 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: Treatment |
| Official Title: | A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
U.S. FDA Resources
Further study details as provided by InSite Vision:
Primary Outcome Measures:
- Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
- Recurrence of Clinical Signs and Symptoms [ Time Frame: 6 Month ] [ Designated as safety issue: Yes ]The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
| Estimated Enrollment: | 900 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ISV-502 |
Drug: ISV-502
Azithromycin and Dexamethasone twice daily for 2 weeks
|
| Active Comparator: AzaSite |
Drug: Azasite
Azasite twice daily for 2 weeks
|
| Active Comparator: Dexamethasone |
Drug: Dexamethasone
Dexamethasone twice daily for 2 weeks
|
| Placebo Comparator: Vehicle |
Other: Vehicle
Vehicle twice daily for 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent Form.
- Are willing and able to follow all instructions and attend all study visits.
- Are willing to avoid disallowed medication for the duration of the study.
- If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
- Additional inclusion criteria also apply.
Exclusion Criteria:
- Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
- Currently suffer from alcohol and/or drug abuse.
- Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
- Have 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: NCT01408082
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Hide Study LocationsLocations
| United States, Arizona | |
| Arizona Eye Center | |
| Chandler, Arizona, United States | |
| Arizona Center for Clinical Trials LLC | |
| Phoenix, Arizona, United States | |
| Cornea Consultants of Arizona | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Lugene Eye Institute | |
| Glendale, California, United States | |
| United Medical Research Institute | |
| Inglewood, California, United States, 90301 | |
| Macy Eye Center | |
| Los Angeles, California, United States, 90048 | |
| North Valley Eye Medical Group, Inc. | |
| Mission Hills, California, United States | |
| Eye Research Foundation | |
| Newport Beach, California, United States | |
| North Bay Associates, Inc. | |
| Petaluma, California, United States | |
| Martel Eye Medical Group | |
| Rancho Cordova, California, United States, 95670 | |
| Shasta Eye Medical Group, Inc. | |
| Redding, California, United States | |
| West Coast Eye Care Associates | |
| San Diego, California, United States | |
| San Diego Eye and Laser Center | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| ZASA Clinical Research, LLC | |
| Boynton Beach, Florida, United States | |
| Florida Eye Microsurgicial Institute, Inc. | |
| Boynton Beach, Florida, United States | |
| Magruder Eye Institute | |
| Orlando, Florida, United States | |
| Vision Eye Care Center | |
| Palm Springs, Florida, United States | |
| International Research Center | |
| Tampa, Florida, United States | |
| United States, Kentucky | |
| Richard Eiferman, MD | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| Lakeview Optical | |
| Gretna, Louisiana, United States | |
| United States, Massachusetts | |
| Center for Sight, Inc. | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Missouri | |
| Tauber Eye Center | |
| Kansas City, Missouri, United States | |
| Ophthalmology Associates | |
| St. Louis, Missouri, United States | |
| Comprehensive Eye Care Ltd | |
| Washington, Missouri, United States | |
| United States, Nevada | |
| Abrams Eye Institute | |
| Las Vegas, Nevada, United States | |
| Nevada Eye Care Professionals | |
| Las Vegas, Nevada, United States | |
| Eye Care Associates of Nevada | |
| Sparks, Nevada, United States | |
| United States, New Jersey | |
| David Ringel, OD PA | |
| Sewell, New Jersey, United States | |
| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| Lynbrook, New York, United States | |
| Ophthalmic Consultants of Long Island | |
| Rockville Centre, New York, United States | |
| Ophthalmic Consultants of Long Island | |
| Valley Stream, New York, United States | |
| South Shore Eye Care | |
| Wantagh, New York, United States | |
| United States, North Carolina | |
| Mundorf Eye Center | |
| Charlotte, North Carolina, United States | |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | |
| Charlotte, North Carolina, United States | |
| James Branch, MD | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Eye Care Associates of Greater Cincinnati, Inc. | |
| Cincinnati, Ohio, United States | |
| Eye Care Associates of Greater Cincinnati, Inc. | |
| Fairfield, Ohio, United States | |
| Eye Care Associates of Greater Cincinnati, Inc. | |
| Madeira, Ohio, United States | |
| United States, Oregon | |
| Roseburg Research Associates, LLC | |
| Roseburg, Oregon, United States, 97471 | |
| United States, Pennsylvania | |
| Philadelphia Eye Associates | |
| Philadelphia, Pennsylvania, United States | |
| Research Across America @ Wyomissing Optometric Center Inc | |
| Wyomissing, Pennsylvania, United States | |
| United States, Tennessee | |
| Total Eye Care, PA | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| David Shulman, MD | |
| San Antonio, Texas, United States | |
| Sun Research Institute | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Daynes Eye and Lasik | |
| Salt Lake City, Utah, United States, 84103 | |
Sponsors and Collaborators
InSite Vision
More Information
No publications provided
| Responsible Party: | InSite Vision |
| ClinicalTrials.gov Identifier: | NCT01408082 History of Changes |
| Other Study ID Numbers: | C-10-502-004 |
| Study First Received: | August 1, 2011 |
| Last Updated: | September 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blepharitis Eyelid Diseases Eye Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Azithromycin Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013