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AL-38583

Phase 2

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

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

Clinical trial landscape

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 small molecule being developed for the treatment of allergic conjunctivitis. It is formulated as an ophthalmic solution and is intended to address inflammation associated with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes AL-38583?

AL-38583 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is conducting clinical research on this ophthalmic solution for allergic conjunctivitis.

What phase is AL-38583 in?

AL-38583 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial for this ophthalmic solution has been completed, and the drug remains under investigation for allergic conjunctivitis.

What clinical trials is AL-38583 in?

AL-38583 has one completed Phase 2 clinical trial registered as NCT01001091, titled "AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation." This randomized, double-blind, placebo-controlled study enrolled 312 participants aged 18 years and older with allergic conjunctivitis.

How does AL-38583 work?

AL-38583 is a small molecule formulated as an ophthalmic solution for allergic conjunctivitis. The specific molecular target of AL-38583 has not been disclosed, so its precise mechanism of action is not publicly detailed. It is being studied for its ability to address inflammation associated with allergic conjunctivitis.