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Also known as Difluprednate 0.05% ophthalmic emulsion
Difluprednate 0.05% emulsion · 2 trials · 2 indications
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
| Arm | Type | Description |
|---|---|---|
| Durezol | EXPERIMENTAL | Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period |
| Pred Forte | ACTIVE_COMPARATOR | Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period |
| Vehicle | PLACEBO_COMPARATOR | Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week. |
| Name | Type | Description |
|---|---|---|
| Difluprednate 0.05% ophthalmic emulsion | DRUG | 1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment |
| Prednisolone acetate 1.0% ophthalmic suspension | DRUG | 1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment |
| Difluprednate vehicle | OTHER | Inactive ingredients used as Run-In and placebo comparator |
Inclusion Criteria: * Diagnosis of endogenous anterior uveitis in at least 1 eye. * The presence of \> 10 cells in the anterior chamber of at least one eye, and a flare score of \> 2 in that same eye. * Age 2 years or older on day of consent. * Negative urine pregnancy test on Day 0 for females of ...
Difluprednate 0.05% emulsion is an ophthalmic corticosteroid being studied for Dry Eye Disease and Endogenous Anterior Uveitis. It is a small molecule formulated as a topical eye emulsion. The dry eye program has completed a Phase 2 trial, and an anterior uveitis trial has also been completed.
Difluprednate 0.05% emulsion targets NR3C1, the glucocorticoid receptor, and acts as an agonist. By binding and activating this receptor, it produces anti-inflammatory effects in ocular tissue. This mechanism underlies its investigation in inflammatory eye conditions such as Dry Eye Disease and Endogenous Anterior Uveitis.
Difluprednate 0.05% emulsion is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating this ophthalmic emulsion in Dry Eye Disease and Endogenous Anterior Uveitis.
Difluprednate 0.05% emulsion is in Phase 2 development for Dry Eye Disease. A completed Phase 3 trial has also evaluated the emulsion in Endogenous Anterior Uveitis. It remains an investigational product and is not approved for these indications.
Two completed trials have studied difluprednate 0.05% emulsion. NCT01276223 was a Phase 2, randomized, double-blind, placebo-controlled trial in Dry Eye Disease that enrolled 722 participants in the United States. NCT01201798 was a Phase 3 trial in Endogenous Anterior Uveitis that enrolled 111 participants.
Yes, difluprednate 0.05% emulsion and difluprednate 0.05% ophthalmic emulsion refer to the same product. The ophthalmic emulsion name describes the topical eye drop formulation. Both names identify the Alcon Inc. small molecule being studied in Dry Eye Disease and Endogenous Anterior Uveitis.