Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01212471 | A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease | PHASE3 | COMPLETED | 840 | — | — | Sep 1, 2010 | Dec 1, 2011 | Sep 4, 2020 | 1 | United States |
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
| Arm | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution A | EXPERIMENTAL | Bromfenac ophthalmic solution A |
| Bromfenac Ophthalmic Solution B | EXPERIMENTAL | Bromfenac ophthalmic solution B |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution A | DRUG | sterile ophthalmic solution |
| Bromfenac Ophthalmic Solution B | DRUG | sterile ophthalmic solution |
| Placebo Comparator | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Be of either gender and any race 18 years or older Exclusion Criteria: * Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study