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Emulsion

Phase 4

Keratoconjunctivitis Sicca | Small molecule | Immunology |AbbVie Inc.|Trials Updated: May 30, 2011

Emulsion development status

Highest phase Phase 4 run by Novartis Vaccines (NCT01069367)
Phase scored for ABBVPhase 3
Registered trials 1 across 1 sponsor since Feb 2010

Emulsion target and mechanism

ModalitySmall molecule

Also known as Ophthalmic Emulsion

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment290

FDA Designations

No designations recorded

Emulsion clinical trials

Emulsion · 1 trial · 5 indications

Phase 3 1
NCT00025818Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeKeratoconjunctivitis Sicca
COMPLETED290 Analytics
PHASE3COMPLETED
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
Keratoconjunctivitis SiccaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Ophthalmic EmulsionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

* Eighteen years or older * Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria: * Diagnosis of autoimmune disorder * Female 65 years of age or older

Countries:United States
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Frequently asked questions about Emulsion

What is Emulsion used for?

Emulsion is an investigational small molecule being studied for keratoconjunctivitis sicca, also known as dry eye syndrome. It was evaluated in a Phase 3 clinical trial in patients with moderate or severe dry eye syndrome. Emulsion has not been approved by the FDA and remains in clinical development.

Who is developing Emulsion?

Emulsion is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating Emulsion in keratoconjunctivitis sicca and related autoimmune conditions.

What phase is Emulsion in?

Emulsion is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study enrolled 290 participants with moderate or severe dry eye syndrome. Emulsion is investigational and has not received FDA approval.

What clinical trials is Emulsion in?

Emulsion has been studied in one completed Phase 3 trial, NCT00025818, titled "Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome." The randomized, double-blind study enrolled 290 participants aged 18 years and older in the United States.

Is Emulsion the same as Ophthalmic Emulsion?

Yes, Emulsion is also known as Ophthalmic Emulsion. Both names refer to the same investigational small molecule developed by AbbVie Inc. for keratoconjunctivitis sicca. The alternative name reflects its ophthalmic formulation and route of administration.

What conditions did the Emulsion trial study?

The Phase 3 trial of Emulsion, NCT00025818, studied patients with moderate or severe dry eye syndrome. Enrolled participants also had related conditions including keratoconjunctivitis sicca, Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, and systemic scleroderma.