Approval Probability
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Also known as bromfenac ophthalmic solution
bromfenac · 8 trials · 6 indications
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
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
| Arm | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution | EXPERIMENTAL | Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
| Placebo | PLACEBO_COMPARATOR | One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
| Bromfenac ophthalmic solution 0.09% | EXPERIMENTAL | dosed 1 drop daily in study eye for 2 weeks |
| Bromfenac | EXPERIMENTAL | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
| 1-bromfenac ophthalmic solution | EXPERIMENTAL | sterile ophthalmic solution |
| 2-placebo comparator | PLACEBO_COMPARATOR | sterile ophthalmic solution |
| Bromfenac Ophthalmic Solution 0.18% | EXPERIMENTAL | - |
| Xibrom 0.09% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution | DRUG | Sterile ophthalmic solution |
| Placebo | DRUG | Sterile ophthalmic solution |
| Placebo Comparator | DRUG | sterile ophthalmic solution |
| Bromfenac | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: * Have known hypersensitivity to bromfenac or to any component of the investigational product
Bromfenac is a small molecule ophthalmic medicine developed by Bausch + Lomb Corporation (ticker BLCO). It is studied in ophthalmology for allergic conjunctivitis, cataract, cataract surgery, pain, and postoperative complications. Bromfenac ophthalmic solution is also the name used for its eye drop formulation.
Bromfenac is used for ophthalmic conditions including allergic conjunctivitis, cataract, cataract surgery, pain, and postoperative complications. Its clinical trial program has focused on patients undergoing cataract surgery, where it has been evaluated for pain and inflammation outcomes in placebo-controlled Phase 3 studies.
Bromfenac targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. By inhibiting PTGS2 and PTGS1, bromfenac belongs to the nonsteroidal anti-inflammatory class of small molecule agents used in eye care.
Bromfenac is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is the sponsor behind the ophthalmic solution program for bromfenac across its studied eye care indications.
Bromfenac is in Phase 3 clinical development. Its Phase 3 program includes completed trials, and no active trials are currently listed. The studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 1,261 participants.
Bromfenac has been studied in completed Phase 3 trials including NCT01367249, NCT00853970, NCT00704418, and NCT00703781. These trials enrolled adults aged 18 years and older in the United States and evaluated bromfenac ophthalmic solution in patients undergoing cataract surgery, with enrollment ranging from 126 to 440 participants.
Yes, bromfenac ophthalmic solution is another name for bromfenac. The terms refer to the same small molecule developed by Bausch + Lomb Corporation, formulated as an eye drop for ophthalmic use in conditions such as cataract surgery, pain, and postoperative complications.