Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebamipide 1% | Active Comparator | Participants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 26 weeks |
|
| Rebamipide 2% | Active Comparator | Participants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 26 weeks |
|
| Placebo | Placebo Comparator | Participants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide 1% | Drug | ophthalmic suspension |
| |
| Rebamipide 2% |
| Measure | Description | Time Frame |
|---|---|---|
| fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12 | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26 | 26 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harold Helms, MD | Birmingham | Alabama | 35205 | United States | ||
| Michael Bernstein, MD |
Not provided
| Label | URL |
|---|---|
| Otsuka Clinical Trial Website: | View source |
| Otsuka Clinical Trial Transparency: | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
ophthalmic suspension |
|
| Placebo | Drug | Rebamipide-matching placebo ophthalmic suspension |
|
| Birmingham |
| Alabama |
| 35216 |
| United States |
| I Care! Eye Care! | Flagstaff | Arizona | 860001 | United States |
| Harvey and Bernice Jones Eye Institute | Little Rock | Arkansas | 72205 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| Benchmark Research | San Francisco | California | 94102 | United States |
| Southern California Clinical Research, Inc. | San Marino | California | 91108 | United States |
| Colorado Eye Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| Danbury Eye Physicians and Surgeons, P.C. | Danbury | Connecticut | 06810-4005 | United States |
| Florida Ophthalmic Institute | Gainesville | Florida | 32605-3192 | United States |
| Florida Wellcare Alliance, L.C. | Inverness | Florida | 34452 | United States |
| Shettle Eye Center | Largo | Florida | 33770 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Tukio Institute for Clinical Research | North Miami Beach | Florida | 33169 | United States |
| Magnolia Research Group, Inc. | Ocala | Florida | 34471 | United States |
| Radiant Research - West Palm Beach | West Palm Beach | Florida | 33407 | United States |
| Vision Incorporated | Savannah | Georgia | 31406 | United States |
| Welborn Clinic | Evansville | Indiana | 47714 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Wichita Clinic, PA | Wichita | Kansas | 67208 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Bossier Optical, Inc. | Bossier City | Louisiana | 71111 | United States |
| Stevenson Medical Surgical Eye Center | New Orleans | Louisiana | 70119 | United States |
| Family Eye Centers | New Orleans | Louisiana | 70127 | United States |
| Ophthalmic Research Associates, Inc. | North Andover | Massachusetts | 01845 | United States |
| Minnesota Eye Associates | Minneapolis | Minnesota | 55404 | United States |
| Depremont Eye Specialists | Gulfport | Mississippi | 39507 | United States |
| Opthalmology Associates | Creve Coeur | Missouri | 63141 | United States |
| Clinical Research Laboratories | Piscataway | New Jersey | 08854 | United States |
| Ophthalmology Associates | Princeton | New Jersey | 08540 | United States |
| Eye Care Associates | Bethpage | New York | 11021 | United States |
| Ophthmalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Mt. Sinai Medical Center School of Medicine | New York | New York | 10029 | United States |
| Ophthalmic Consultants of Long Island | New York | New York | 11570 | United States |
| Rochester Ophthalmological Group | Rochester | New York | 14618 | United States |
| Ophthalmic Consultants of Long Island | Valley Stream | New York | 11581 | United States |
| Western Wake Eye Center, P.A. | Cary | North Carolina | 27511 | United States |
| Southeast Clinical Research Associates | Charlotte | North Carolina | 28210 | United States |
| Horizon Eye Care - Clinical Research Dept. | Charlotte | North Carolina | 28211 | United States |
| Cornerstone Research Care | High Point | North Carolina | 27262 | United States |
| Carolina Eye Associates | Southern Pines | North Carolina | 28387 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Comprehensive Opthalmology & Optical Services | Cleveland | Ohio | 44115 | United States |
| Bend Medical Clinic | Bend | Oregon | 97701 | United States |
| Medical Eye Center | Medford | Oregon | 97504 | United States |
| Valley Clinical Research Center | Easton | Pennsylvania | 18045 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | United States |
| University of Pittsburg Eye and Ear Institute | Pittsburgh | Pennsylvania | 15233 | United States |
| Glaucome-Cataract Consultants | Pittsburgh | Pennsylvania | 15243 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| Corona Research Consultants, Inc. | El Paso | Texas | 79904 | United States |
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Physician Research Network | Houston | Texas | 77002 | United States |
| Houston | Texas | 77002 | United States |
| Medical Center Ophthalmology | Houston | Texas | 77030 | United States |
| Houston Eye Associates | Houston | Texas | 77125 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Eye Clinic of South Texas | San Antonio | Texas | 78209 | United States |
| Advanced Healthcare Clinical Research Center | Milwaukee | Wisconsin | 21209 | United States |
| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C052785 | rebamipide |
Not provided
Not provided
Not provided