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Hydroxypropyl Guar Galactomannan

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jan 6, 2010

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00760045Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up TimePHASE2 COMPLETED 40Aug 1, 2008 -Jan 6, 20101 Japan
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Study Endpoints
Primary Endpoints
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Up to 180 minutes
Secondary Endpoints
Ocular comfort
After installation
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAL-43546 0.15%
2EXPERIMENTALAL-43546 0.25%
3ACTIVE_COMPARATORAL-43546 0%(Vehicle)
4ACTIVE_COMPARATOR0.1% sodium hyaluronate ophthalmic solutio
Interventions
NameTypeDescription
Hydroxypropyl Guar GalactomannanDRUGOne drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
0.1% sodium hyaluronate ophthalmic solutionDRUGOne drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
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Eligibility Criteria
Age Range20 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less. Exclusion Criteria: * Diagnosis of severe Sjogren's syndrome (history of the use of pun...

Countries:Japan
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