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AL-38583

Phase 2

Allergic Conjunctivitis | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Jul 17, 2014

AL-38583 target and mechanism

ModalitySmall molecule

Also known as AL-38583 ophthalmic solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment312

FDA Designations

No designations recorded

AL-38583 clinical trials

AL-38583 · 1 trial · 1 indication

Phase 2 1
NCT01001091AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated InflammationAllergic Conjunctivitis
COMPLETED312 Analytics
PHASE2COMPLETED
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Allergic ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Day 14

Secondary Endpoints

Mean daily diary ocular redness scores
2 week period between Day 0 and Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL-38583 0.01%EXPERIMENTALAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 0.05%EXPERIMENTALAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 0.2%EXPERIMENTALAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 VehiclePLACEBO_COMPARATORAL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
MAXIDEXACTIVE_COMPARATORDexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks

Interventions

NameTypeDescription
AL-38583 ophthalmic solutionDRUG -
AL-38583 ophthalmic solution vehicleDRUGInactive ingredients used as a placebo comparator
Dexamethasone ophthalmic suspension, 0.1%DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Presence of signs and symptoms of ocular inflammation in both eyes. * Have a positive CAC response at Visit 1. * Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study. * Other p...

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Frequently asked questions about AL-38583

What is AL-38583 used for?

AL-38583 is an investigational ophthalmic solution being developed for allergic conjunctivitis and the associated inflammation of the eye. It is a small molecule formulated for topical use in the eye. Alcon Inc. has studied it in a Phase 2 clinical trial in adults with allergic conjunctivitis.

Who makes AL-38583?

AL-38583 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and AL-38583 is part of its ophthalmology pipeline. The drug is an ophthalmic solution small molecule being studied for allergic conjunctivitis.

What phase is AL-38583 in?

AL-38583 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial of AL-38583 has been completed, and no trials of the drug are currently listed as active.

What clinical trials is AL-38583 in?

AL-38583 has been studied in the Phase 2 trial NCT01001091, titled AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation. That trial enrolled 312 participants, was randomized, double blind, and placebo controlled, and it is now completed. Participants were adults 18 years and older.

Is AL-38583 the same as AL-38583 ophthalmic solution?

Yes. AL-38583 ophthalmic solution is the same asset as AL-38583, referring to the topical eye drop formulation studied in clinical trials. Searches for either name point to the same Alcon Inc. development program for allergic conjunctivitis.