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The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difluprednate 0.05% BID | Experimental | Difluprednate 0.05% 1 drop BID for 14 days. |
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| Difluprednate 0.05% QID | Experimental | Difluprednate 0.05% 1 drop QID for 14 days. |
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| Placebo | Placebo Comparator | Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate | Drug |
| ||
| Difluprednate |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). | Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells. | Day 8 (QID) |
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Inclusion Criteria:
Presurgical Exclusion Criteria:
Postsurgical Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Vogel, MD | Sirion Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Eye Care | Washington | Missouri | 63090 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19101421 | Derived | Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024. |
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Subjects enrolled if, 24 hours after ocular surgery, they had an anterior chamber cell grade of ≥ "2" and met the protocol inclusion and exclusion criteria.
First subject enrolled February 6, 2007 and last subject completed September 17, 2007 at 13 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Difluprednate 0.05% BID | Difluprednate 0.05% 1 drop BID for 14 days. |
| FG001 | Difluprednate 0.05% QID | Difluprednate 0.05% 1 drop QID for 14 days. |
| FG002 | Placebo | Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Difluprednate 0.05% BID | Difluprednate 0.05% 1 drop BID for 14 days. |
| BG001 | Difluprednate 0.05% QID | Difluprednate 0.05% 1 drop QID for 14 days. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). | Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells. | The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29. | Posted | Number | participants | Day 8 (QID) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Brace | Sirion Therapeutics, Inc. | 813-496-7325 | 343 | jbrace@siriontherapeutics.com |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C015808 | difluprednate |
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| Placebo | Drug |
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| Lost to Follow-up |
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| Withdrew Consent |
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| Early Termination |
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| BG002 | Placebo | Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | Placebo | Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. |
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