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Hydroxypropyl Guar Galactomannan

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Hydroxypropyl Guar Galactomannan · 1 trial · 1 indication

Phase 2 1
NCT00760045Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up TimeDry Eye Disease
COMPLETED40 Analytics
PHASE2COMPLETED
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Dry Eye DiseaseUnlock trial analytics

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 to 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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Competitive Landscape -Dry Eye Disease 7 trials

Frequently asked questions about Hydroxypropyl Guar Galactomannan

What is Hydroxypropyl Guar Galactomannan used for?

Hydroxypropyl Guar Galactomannan is an investigational small molecule being developed for Dry Eye Disease. It is in Phase 2 clinical development, meaning it has not yet been approved and remains under study to evaluate its safety and effectiveness for this condition.

Who makes Hydroxypropyl Guar Galactomannan?

Hydroxypropyl Guar Galactomannan is being developed by Alcon Inc., a company traded on the stock exchange under the ticker ALC. Alcon is conducting clinical research on this drug candidate for the treatment of Dry Eye Disease.

What phase is Hydroxypropyl Guar Galactomannan in?

Hydroxypropyl Guar Galactomannan is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being studied for its potential use in treating Dry Eye Disease. One Phase 2 trial has been completed.

What clinical trials is Hydroxypropyl Guar Galactomannan in?

Hydroxypropyl Guar Galactomannan has one completed Phase 2 clinical trial registered as NCT00760045. This study, titled "Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time," enrolled 40 participants in Japan.

Is Hydroxypropyl Guar Galactomannan the same as AL-43546?

Yes, Hydroxypropyl Guar Galactomannan is the same as AL-43546. The clinical trial NCT00760045 refers to the drug as AL-43546 Ophthalmic Product, indicating that AL-43546 is an alternative name for this drug candidate.