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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-502 | Experimental |
| |
| AzaSite | Active Comparator |
| |
| Dexamethasone | Active Comparator |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) | Drug | Azithromycin and Dexamethasone twice daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15. | Day 15 |
| Recurrence of Clinical Signs and Symptoms | The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up. | 6 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | United States | |||
| Arizona Center for Clinical Trials LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29325546 | Derived | Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5. |
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| Azasite | Drug | Azasite twice daily for 2 weeks |
|
| Dexamethasone | Drug | Dexamethasone twice daily for 2 weeks |
|
| Vehicle | Other | Vehicle twice daily for 2 weeks |
|
| Phoenix |
| Arizona |
| United States |
| Cornea Consultants of Arizona | Phoenix | Arizona | United States |
| Lugene Eye Institute | Glendale | California | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| Macy Eye Center | Los Angeles | California | 90048 | United States |
| 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 | 95670 | United States |
| Shasta Eye Medical Group, Inc. | Redding | California | United States |
| San Diego Eye and Laser Center | San Diego | California | 92123 | United States |
| West Coast Eye Care Associates | San Diego | California | United States |
| Florida Eye Microsurgicial Institute, Inc. | Boynton Beach | Florida | United States |
| ZASA Clinical Research, LLC | 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 |
| Richard Eiferman, MD | Louisville | Kentucky | United States |
| Lakeview Optical | Gretna | Louisiana | United States |
| Center for Sight, Inc. | Fall River | Massachusetts | 02720 | United States |
| Tauber Eye Center | Kansas City | Missouri | United States |
| Ophthalmology Associates | St Louis | Missouri | United States |
| Comprehensive Eye Care Ltd | Washington | Missouri | United States |
| 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 |
| David Ringel, OD PA | Sewell | New Jersey | United States |
| 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 |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Charlotte | North Carolina | United States |
| Mundorf Eye Center | Charlotte | North Carolina | United States |
| James Branch, MD | Winston-Salem | North Carolina | United States |
| 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 |
| Roseburg Research Associates, LLC | Roseburg | Oregon | 97471 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | United States |
| Research Across America @ Wyomissing Optometric Center Inc | Wyomissing | Pennsylvania | United States |
| Total Eye Care, PA | Memphis | Tennessee | United States |
| David Shulman, MD | San Antonio | Texas | United States |
| Sun Research Institute | San Antonio | Texas | United States |
| Daynes Eye and Lasik | Salt Lake City | Utah | 84103 | United States |
| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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