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Systane COMPLETE Lubricant Eye

Phase 2

Dry Eye Syndromes | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Dec 2, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06188260Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye DiseasePHASE2 COMPLETED 31Jan 16, 2024Nov 4, 2024Dec 2, 20241 Hong Kong
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Study Endpoints
Primary Endpoints
Ocular Surface Disease Index (OSDI)
Change in OSDI score at 2-week visit

Change in OSDI score at 2-week visit

Secondary Endpoints
Non invasive tear break-up time (NITBUT)
NITBUT at 2-week and 3-month visits
Meibography
Meibography at 2-week and 3-month visits
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dry eye participantsEXPERIMENTALParticipants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT\<10s; 3) osmolarity \>=308, or difference \>8
Interventions
NameTypeDescription
Systane COMPLETE Lubricant Eye DropsDRUGActive Ingredients: Propylene Glycol 0.6% Purpose: Lubricant
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Eligibility Criteria
Age Range20 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 20-50 years old 2. Best corrected distance visual acuity ≥ 6/9 3. Mild to moderate OSDI score 13-32 4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity) Exclusion Criteria: 1. Any active ocular infections 2. Inflammations or an...

Countries:Hong Kong
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
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