Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Bromfenac Topical bromfenac ophthalmic solution 0.1% |
Drug: Bromfenac
One drop in study eye every 12 hours for 14 days
|
Placebo Comparator: Placebo Vehicle of bromfenac |
Drug: Placebo
One drop in study eye every 12 hours for 14 days
|
Outcome Measures
Primary Outcome Measures
- Ocular Inflammation Score [Visit 4 (Day 15)]
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
Secondary Outcome Measures
- Mean Ocular Inflammation Score [At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)]
Mean change from baseline in SOIS at each visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Cataract surgery
-
Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
-
Agreed to avoid disallowed medications (meds) throughout the duration of the study
Exclusion Criteria:
-
Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
-
Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
-
Extraocular/intraocular inflammation in either eye
-
Clinically significant (WHO CTC Grade 1 or greater) liver function tests
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Harold A Helms, MD | Birmingham | Alabama | United States | 35205 |
2 | Eye Care Arkansas, PA | Little Rock | Arkansas | United States | 72205 |
3 | UCI, Department of Ophthalmology | Irvine | California | United States | 92697 |
4 | Anesthetic Eye Care Institute | Newport Beach | California | United States | 92663 |
5 | Richard A Lewis, MD | Sacramento | California | United States | 95819 |
6 | Eye Care of San Diego | San Diego | California | United States | 92103 |
7 | Santa Clara Valley Medical Center | San Jose | California | United States | 95128 |
8 | E Randy Craven, MD | Littleton | Colorado | United States | 80120 |
9 | The Eye Care Group | New Haven | Connecticut | United States | 06510 |
10 | Cohen Laser Vision Center | Boca Raton | Florida | United States | 33431 |
11 | Brandon Cataract Center & Eye Clinic | Brandon | Florida | United States | 33511 |
12 | Marvin E Greenberg, MD, PA | Tamarac | Florida | United States | 33321 |
13 | Jack Daubert, MD | West Palm Beach | Florida | United States | 33401 |
14 | Advanced Eye Care, PC | Fort Oglethorpe | Georgia | United States | 30742 |
15 | Saltzer Medical Group, PA | Nampa | Idaho | United States | 83686 |
16 | Donald E Beahm, MD | Great Bend | Kansas | United States | 67530 |
17 | Cincinnati Eye Institute NKY | Edgewood | Kentucky | United States | 41017 |
18 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
19 | Stevenson Medical Surgical Eye Center | New Orleans | Louisiana | United States | 70119 |
20 | Cornea Consultants | Boston | Massachusetts | United States | 02114 |
21 | Great Lakes Eye Care | St. Joseph | Michigan | United States | 49085 |
22 | Hunkeler Eye Institute | Kansas City | Missouri | United States | 64111 |
23 | Arthur J Weinstein, MD | Albuquerque | New Mexico | United States | 87102 |
24 | Ophthalmic Consultants of Long Island | Rockville Centre | New York | United States | 11570 |
25 | Horizon Eye Care | Charlotte | North Carolina | United States | 28211 |
26 | Dean A McGee Eye Institute | Oklahoma City | Oklahoma | United States | 73104 |
27 | The Eye Institute | Tulsa | Oklahoma | United States | 74104 |
28 | Casey Eye Institute | Portland | Oregon | United States | 97201 |
29 | Eye Health Northwest | Portland | Oregon | United States | 97209 |
30 | Scheie Eye Institute | Philadelphia | Pennsylvania | United States | 19104 |
31 | Black Hills Regional Eye Institute | Rapid City | South Dakota | United States | 57701 |
32 | Middle Tennessee Eye Associates | Cookeville | Tennessee | United States | 38501 |
33 | Texan Eye Care PA | Austin | Texas | United States | 78705 |
34 | Ophthalmology Service, Brooke Army Medical Center | Ft. Sam Houston | Texas | United States | 78234 |
35 | Ophthalmology Visual Science | Galveston | Texas | United States | 77555 |
36 | Houston Eye Associates | Houston | Texas | United States | 77025 |
37 | David G Shulman, MD | San Antonio | Texas | United States | 78209 |
38 | Central Texas Eye Center | San Marcos | Texas | United States | 78666 |
39 | Virginia Eye Consultants | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISTA-BR-CS001