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AL-39256, 1%

Phase 2

Open-Angle Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

AL-39256, 1% · 1 trial · 2 indications

Phase 2 1
NCT00761709Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular HypertensionOpen-Angle Glaucoma
COMPLETED104 Analytics
PHASE2COMPLETED
Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Open-Angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in IOP
Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL-39256EXPERIMENTALAL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.
XALATANACTIVE_COMPARATORLatanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.
VehiclePLACEBO_COMPARATORInactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Interventions

NameTypeDescription
AL-39256 Ophthalmic Suspension, 1%DRUG -
Latanoprost Ophthalmic Solution, 0.005%DRUG -
VehicleDRUGInactive ingredients used as a placebo comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with open-angle glaucoma or ocular hypertension. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Females of childbearing potential. * Other protocol-defined exclusion criteria may apply.

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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about AL-39256, 1%

What is AL-39256 used for?

AL-39256 is an investigational small molecule being developed for the treatment of open-angle glaucoma. It is formulated as a 1% ophthalmic solution and is intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Who is developing AL-39256?

AL-39256 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company focused on eye care, including ophthalmology products.

What phase is AL-39256 in?

AL-39256 is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities. Further clinical development would be required before any potential approval.

What clinical trials has AL-39256 been in?

AL-39256 has been studied in one completed Phase 2 clinical trial, identified as NCT00761709. This trial evaluated the safety and intraocular pressure-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension. The study enrolled 104 participants and was randomized, double-blind, and placebo-controlled.

Is AL-39256 the same as any other drug?

AL-39256 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is a distinct small molecule being developed by Alcon for ophthalmic use.