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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac | Experimental | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
|
| Placebo | Placebo Comparator | Placebo, Dosed 1 Drop Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bromfenac ophthalmic solution | Drug | sterile ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 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) | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Are Pain Free | Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
A total of 126 subjects were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 63 were randomized to the bromfenac ophthalmic solution treatment group and 63 were randomized to the placebo treatment group.
Study start date was 06/10/2008 and last participant to exit the study was 09/02/2008. This study was conducted in 18 study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
| FG001 | Placebo | Placebo, Dosed 1 Drop Daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
| BG001 | Placebo | Placebo, Dosed 1 Drop Daily |
| 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 | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 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) | Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT) | Posted | Number | Participants | Day 15 |
|
2 weeks
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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 | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Edema | Eye disorders | MedDRA 8.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | 949-788-6000 | tmcnamara@istavision.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| placebo |
| Drug |
sterile ophthalmic solution |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants That Are Pain Free | Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop | LOCF Analysis, ITT Population | Posted | Number | Participants | Day 1 |
|
|
|
| 2 |
| 61 |
| 46 |
| 61 |
| EG001 | Placebo | Placebo, Dosed 1 Drop Daily | 0 | 61 | 61 | 61 |
| Renal Failure | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA 8.1 | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Eye Inflammation | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Eye Pruritus | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Foreign Body Sensation | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ocular Hyperemia | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
The disclosure restriction on the PI is that the PI will provide to the sponsor a copy of proposed publication information for review, comment and approval following completion of the study and at least sixty (60) days prior to submission of the publication. If sponsor requests in writing, the PI will withhold publication until written permission is given by sponsor.