10 completed, 2 terminated. 8 Phase 3, 3 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 8 |
| Phase 4 | 3 | Terminated 2, Completed 1 |
| Phase 2 | 1 | Completed 1 |
Follow difluprednate: new trials by email Literature Review of difluprednate trials Research Report on difluprednate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery Dextenza 0.4mg intracanalicular Insert, Durezol 0.05% Ophthalmic Emulsion - Cataract | Phase 4 | Terminated | Cathleen McCabe MD | 1 | 2020-12-01 | 2022-11-10 |
| Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification Difluprednate 0.05%, Prednefrin - Cataract | Phase 3 | Completed | Laboratorios Sophia S.A de C.V. | 178 | 2018-10-04 | 2019-12-02 |
| Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Difluprednate, Nepafenac, Prednisolone acetate - Uveitis, Macular Edema | Phase 4 | Terminated | University of California, San Francisco | 9 | 2018-09-12 | 2021-01-13 |
| Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients Difluprednate 0.05% ophthalmic emulsion, Difluprednate vehicle - Dry Eye Disease | Phase 2 | Completed | Alcon Research | 722 | 2011-02-01 | 2013-03-11 |
| Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis Difluprednate 0.05% ophthalmic emulsion, Prednisolone acetate 1.0% ophthalmic suspension - Endogenous Anterior Uveitis | Phase 3 | Completed | Alcon Research | 111 | 2010-10-01 | 2012-11-15 |
| Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery Difluprednate ophthalmic emulsion, 0.05%, Prednisolone acetate ophthalmic suspension, 1.0% - Cataracts, Inflammation | Phase 3 | Completed | Alcon Research | 80 | 2010-08-01 | 2013-06-19 |
| Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery. Difluprednate ophthalmic emulsion 0.05%, Prednisolone acetate 1% - Cataracts, Corneal Edema | Phase 4 | Completed | Edward J. Holland | 52 | 2009-03-01 | 2012-08-08 |
| Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004) Difluprednate, Placebo - Inflammation | Phase 3 | Completed | Sirion Therapeutics, Inc. | 120 | 2008-01-01 | 2011-07-01 |
| Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003) Difluprednate, Placebo - Inflammation | Phase 3 | Completed | Sirion Therapeutics, Inc. | 120 | 2007-12-01 | 2011-06-30 |
| Study of Difluprednate in the Treatment of Uveitis Difluprednate, Prednisolone Acetate - Uveitis | Phase 3 | Completed | Sirion Therapeutics, Inc. | 2008-08-29 | ||
| Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a) Difluprednate, Placebo - Inflammation | Phase 3 | Completed | Sirion Therapeutics, Inc. | 219 | 2009-07-02 | |
| Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b) Difluprednate, Placebo - Inflammation | Phase 3 | Completed | Sirion Therapeutics, Inc. | 219 | 2009-07-02 |
Inflammation (5) · Cataract (4) · Uveitis (2) · Corneal Edema (1) · Dry Eye Syndromes (1) · Macular Edema (1)
Sirion Therapeutics, Inc. (5) · Alcon Research (3) · Cathleen McCabe MD (1) · Edward J. Holland (1) · Laboratorios Sophia S.A de C.V. (1) · University of California, San Francisco (1)
United States (10) · India (1) · Mexico (1)
Roger Vogel, MD (5) · Cathleen M McCabe, MD (1) · Edward J Holland, MD (1) · Eric D Donnenfeld, MD (1) · Kerry S Solomon, MD (1) · Nisha Acharya, MD MS (1)
PMID 19101421, PMID 20809807, PMID 21704965, PMID 24677110, PMID 32606573