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Difluprednate Emulsion

Phase 2

Inflammation | Small molecule | Immunology |cbdMD, Inc.|Last Updated: Dec 6, 2006

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Difluprednate Emulsion · 1 trial · 1 indication

Phase 2 1
NCT00407225Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative InflammationInflammation
COMPLETED24 Analytics
PHASE2COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
Inflammation
NCT0040722524
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Study Endpoints

Primary Endpoints

The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.

Secondary Endpoints

The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
with the baseline total score (S0).
As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Difluprednate Ophthalmic EmulsionDRUG -
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Eligibility Criteria

Age Range12 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec * Male and female patients aged 12 and \<75 years who were able to accurately express their own symptoms * Patients providing written informed consent...

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Frequently asked questions about Difluprednate Emulsion

What is Difluprednate Emulsion used for?

Difluprednate Emulsion is used for inflammation. It is being studied as a treatment for postoperative inflammation, according to a completed Phase 2 clinical trial. The drug is a small molecule being developed by cbdMD, Inc. for the immunology therapeutic area.

Who makes Difluprednate Emulsion?

Difluprednate Emulsion is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is a small molecule intended for the treatment of inflammation, and it has completed a Phase 2 clinical trial for postoperative inflammation.

What phase is Difluprednate Emulsion in?

Difluprednate Emulsion is in Phase 2 clinical development. It is an investigational drug, not yet approved by the FDA. The drug has completed one Phase 2 trial for postoperative inflammation, and it is being studied for the treatment of inflammation.

What clinical trials is Difluprednate Emulsion in?

Difluprednate Emulsion has one completed clinical trial, NCT00407225, titled "Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation." This Phase 2 trial enrolled 24 participants aged 12 years and older, and it was randomized, double-blind, and uncontrolled.

Is Difluprednate Emulsion the same as Difluprednate?

Difluprednate Emulsion is a formulation of the drug difluprednate. The clinical trial NCT00407225 refers to it as "Difluprednate Ophthalmic Emulsion," indicating that the emulsion is the specific dosage form being studied for postoperative inflammation.

How does Difluprednate Emulsion work?

Difluprednate Emulsion is a corticosteroid that works by reducing inflammation. It is being studied for the treatment of postoperative inflammation, and the completed Phase 2 trial evaluated its efficacy in that setting. The drug is administered as an ophthalmic emulsion.