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Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac ophthalmic solution 0.09% | Experimental | dosed 1 drop daily in study eye for 2 weeks |
|
| Placebo | Placebo Comparator | dosed 1 drop daily in study eye for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac Ophthalmic Solution | Drug | sterile ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Ocular Inflammation Score (SOIS) of Zero | 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) | Day 15 (Primary Endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Free | Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe. | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21751945 | Derived | Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14. |
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152 participants were randomized to the bromfenac ophthalmic solution 0.09% treatment group and 147 were randomized to the placebo treatment group. One hundred forty six of 152 participants (96.1%) in the bromfenac ophthalmic solution 0.09% treatment group and 144/147 (98.0%) participants in the placebo treatment group completed the study.
The first participant entered the study on 02/09/2009, and last participant exited the study on 07/06/2009. This study took place at 41 sites in the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac Ophthalmic Solution 0.09% | dosed 1 drop daily into the study eye for 2 weeks |
| FG001 | Placebo | dosed 1 drop daily into the study eye for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Ophthalmic Solution 0.09% | one drop daily in study eye for 2 weeks |
| BG001 | Placebo | one drop daily in study eye for 2 weeks |
| 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 | Summed Ocular Inflammation Score (SOIS) of Zero | 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) | Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population | Posted | Number | participants | Day 15 (Primary Endpoint) |
|
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 Ophthalmic Solution 0.09% | one drop daily in study eye for 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute and chronic pancreatitis | Endocrine disorders | MedDRA (8.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperemia | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim McNamara, Vice President, Clinical Research & Medical Affairs | ISTA Pharmaceuticals, Inc. | 949-788-6000 | tmcnamara@istavision.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Placebo Comparator |
| Drug |
sterile ophthalmic solution |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Free | Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe. | Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population | Posted | Number | participants | Day 1 |
|
|
|
| 0 |
| 147 |
| 69 |
| 147 |
| EG001 | Placebo | one drop daily in study eye for 2 weeks | 3 | 144 | 86 | 144 |
| Eye and ear procedural complications | Surgical and medical procedures | MedDRA (8.1) | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Eye Inflammation | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Foreign body sensation | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Ocular Hyperemia | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (8.1) | Non-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.