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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 | Drug | sterile ophthalmic solution |
| |
| Placebo |
| 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; 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 (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses | 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 |
| 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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A total of 156 participants were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 78 were randomized to the bromfenac ophthalmic solution treatment group and 78 were randomized to the placebo treatment group.
This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.
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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; 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), ITT Population | Posted | Number | participants | Day 15 |
|
14 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 | Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal oedema | 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 |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
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| 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 (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses | LOCF Analysis, ITT Population | Posted | Number | participants | Day 1 |
|
|
|
| 0 |
| 73 |
| 6 |
| 73 |
| EG001 | Placebo | Placebo, dosed 1 drop daily | 0 | 73 | 19 | 73 |
| Eye Pain | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Eye Inflammation | 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.