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This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac Ophthalmic Solution | Drug | Sterile ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation | The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Pain | The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
440 subjects were enrolled from 39 clinical sites in the United States, of which 416 subjects received at least 1 dose of bromfenac or placebo.
This study was a multi-center, randomized, double-masked, parallel-group, placebo-controlled study, the first subject was enrolled 05/05/2011 and the last subject exited the study 07/29/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac Ophthalmic Solution | 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. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution |
| FG001 | Placebo | 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. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat population (ITT), all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Ophthalmic Solution | 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. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Inflammation | The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15. | LOCF Analysis, ITT Population | Posted | Number | eyes | Day 15 | eyes | Participants |
|
16 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bromfenac Ophthalmic Solution | 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. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment | Subject recovered and the AE resolved |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Inflammation | Eye disorders | Medra | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Gow | Bausch & Lomb Incorporated | 949-788-6000 | james.gow@bausch.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Placebo |
| Drug |
Sterile ophthalmic solution |
|
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. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Iris Color (Study Eye) | Number | participants |
|
|
|
| Secondary | Ocular Pain | The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary. | LOCF Analysis, ITT Population | Posted | Number | eyes | Day 1 | eyes | Participants |
|
|
|
| 3 |
| 212 |
| 29 |
| 212 |
| EG001 | Placebo | 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. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution | 4 | 204 | 54 | 204 |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Eye operation complication | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Deep Vein Thrombosis | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Asthenia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Myocarial Infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Conjunctival Hyperemia | Eye disorders | Medra | Systematic Assessment |
|
| Eye Pain | Eye disorders | Medra | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D007905 | Lens Diseases |
| D005128 | Eye Diseases |