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| Name | Class |
|---|---|
| Sirion Therapeutics, Inc. | INDUSTRY |
| Alcon Research | INDUSTRY |
| Parsons Medical Communications | UNKNOWN |
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The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difluprednate Ophthalmic Emulsion 0.05% | Active Comparator |
| |
| Prednisolone acetate suspension 0.1% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate ophthalmic emulsion 0.05% | Drug | Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1 | Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 | change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30 | change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward J Holland, MD | Cincinnati Eye Institute | Principal Investigator |
| Eric D Donnenfeld, MD | Ophthalmic Consultants of Long Island | Principal Investigator |
| Kerry S Solomon, MD | Carolina Eyecare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States | ||
| Ophthalmic Consultants of Long Island |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21704965 | Derived | Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 29, 2013 | |
| Reset | Oct 8, 2013 | |
| Release | Aug 11, 2014 |
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|
| Prednisolone acetate 1% | Drug | Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop. |
|
|
| Lynbrook |
| New York |
| 11563 |
| United States |
| Carolina Eyecare | Mt. Pleasant | South Carolina | 29464 | United States |
| Reset | Aug 25, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2013 | Oct 8, 2013 | |||
| Aug 11, 2014 | Aug 25, 2014 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
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| ID | Term |
|---|---|
| C015808 | difluprednate |
| C009935 | prednisolone acetate |
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