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Systane Ultra eyedrops

Phase 3

Xerophthalmia | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Oct 7, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Systane Ultra eyedrops · 1 trial · 2 indications

Phase 3 1
NCT00796926Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian EyesXerophthalmia
COMPLETED30 Analytics
PHASE3COMPLETED
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
XerophthalmiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual Analog Score (VAS)
6 weeks

Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum

Secondary Endpoints

Corneal Fluorescein Staining Score
6 weeks
Tear Break Up Time (TBUT)
6 weeks
Schirmer I Reading
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Systane UltraEXPERIMENTALUsed four times a day topically to each eye
RefreshACTIVE_COMPARATORUsed four times a day topically to each eye

Interventions

NameTypeDescription
Systane Ultra eyedropsDRUGFour times a day
Refresh eye dropsDRUGFour times a day
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Eligibility Criteria

Age Range40 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject age is between 40 and 65 years old. 2. Corneal fluorescein staining present in at least one/five sectors of at least one cornea 3. At least one question out of 6 questions on dry eye symptom present often or all the time. based on the Salisbury Eye study by Oliver...

Countries:Singapore
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Frequently asked questions about Systane Ultra eyedrops

What is Systane Ultra used for?

Systane Ultra is used for the treatment of xerophthalmia, commonly known as dry eye. It is an ophthalmology product developed by Alcon Inc. and is currently in Phase 3 clinical development for this condition.

What does Systane Ultra target?

Systane Ultra is a small molecule product that targets the ocular surface to relieve symptoms of dry eye. It is designed to provide lubrication and moisture to the eye, addressing the discomfort associated with xerophthalmia.

Who makes Systane Ultra?

Systane Ultra is developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is focused on eye care products, including treatments for dry eye.

What phase is Systane Ultra in?

Systane Ultra is in Phase 3 clinical development. It is an investigational product for the treatment of dry eye, and it is not yet approved by regulatory authorities.

What clinical trials is Systane Ultra in?

Systane Ultra has one completed Phase 3 clinical trial, identified as NCT00796926. This trial compared the efficacy of Systane Ultra with a control in treating dry eye in Asian eyes, enrolling 30 participants in Singapore.

Is Systane Ultra the same as Refresh Drop?

Systane Ultra is not the same as Refresh Drop. In a clinical trial, Systane Ultra was compared against Refresh Drop as an active control to evaluate its efficacy in treating dry eye. They are separate products.