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The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac | Experimental | Topical bromfenac ophthalmic solution 0.1% |
|
| Placebo | Placebo Comparator | Vehicle of bromfenac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac | Drug | One drop in study eye every 12 hours for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation Score | Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none | Visit 4 (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Inflammation Score | Mean change from baseline in SOIS at each visit. | At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harold A Helms, MD | Birmingham | Alabama | 35205 | United States | ||
| Eye Care Arkansas, PA |
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| Placebo |
| Drug |
One drop in study eye every 12 hours for 14 days |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| UCI, Department of Ophthalmology | Irvine | California | 92697 | United States |
| Anesthetic Eye Care Institute | Newport Beach | California | 92663 | United States |
| Richard A Lewis, MD | Sacramento | California | 95819 | United States |
| Eye Care of San Diego | San Diego | California | 92103 | United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| E Randy Craven, MD | Littleton | Colorado | 80120 | United States |
| The Eye Care Group | New Haven | Connecticut | 06510 | United States |
| Cohen Laser Vision Center | Boca Raton | Florida | 33431 | United States |
| Brandon Cataract Center & Eye Clinic | Brandon | Florida | 33511 | United States |
| Marvin E Greenberg, MD, PA | Tamarac | Florida | 33321 | United States |
| Jack Daubert, MD | West Palm Beach | Florida | 33401 | United States |
| Advanced Eye Care, PC | Fort Oglethorpe | Georgia | 30742 | United States |
| Saltzer Medical Group, PA | Nampa | Idaho | 83686 | United States |
| Donald E Beahm, MD | Great Bend | Kansas | 67530 | United States |
| Cincinnati Eye Institute NKY | Edgewood | Kentucky | 41017 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Stevenson Medical Surgical Eye Center | New Orleans | Louisiana | 70119 | United States |
| Cornea Consultants | Boston | Massachusetts | 02114 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Hunkeler Eye Institute | Kansas City | Missouri | 64111 | United States |
| Arthur J Weinstein, MD | Albuquerque | New Mexico | 87102 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Horizon Eye Care | Charlotte | North Carolina | 28211 | United States |
| Dean A McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Casey Eye Institute | Portland | Oregon | 97201 | United States |
| Eye Health Northwest | Portland | Oregon | 97209 | United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Middle Tennessee Eye Associates | Cookeville | Tennessee | 38501 | United States |
| Texan Eye Care PA | Austin | Texas | 78705 | United States |
| Ophthalmology Service, Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Ophthalmology Visual Science | Galveston | Texas | 77555 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| David G Shulman, MD | San Antonio | Texas | 78209 | United States |
| Central Texas Eye Center | San Marcos | Texas | 78666 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
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