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Hydroxypropyl Guar Galactomannan 0.25%

Phase 2

Dry Eye | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 17, 2014

Target and mechanism

ModalitySmall molecule

Also known as Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment427

FDA Designations

No designations recorded

Clinical trial landscape

Hydroxypropyl Guar Galactomannan 0.25% · 1 trial · 1 indication

Phase 2 1
NCT00840268A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye PatientsDry Eye
COMPLETED427 Analytics
PHASE2COMPLETED
A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
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Study Endpoints

Primary Endpoints

Mean change from baseline in sodium fluorescein corneal staining score
Baseline (Day 7), Up to Day 28

Secondary Endpoints

Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score
Baseline (Day 7), Up to Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HPGG 0.25%EXPERIMENTALHydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).
HPGG VehiclePLACEBO_COMPARATORHydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).

Interventions

NameTypeDescription
Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gelDRUG -
Hydroxypropyl Guar Galactomannan VehicleDRUGInactive ingredients used as a placebo comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must read, sign, and date an informed consent document and HIPAA privacy document. * Diagnosis of dry eye at Visit 1 (Day 0). * Able and willing to follow study instructions. * Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS c...

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