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AL-39256, 1%

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as AL-39256 Ophthalmic Suspension, 1%

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, 1%?

AL-39256, 1% is an investigational small molecule eye drop developed by Alcon Inc. (ticker ALC) for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is formulated as a 1% ophthalmic suspension and has been studied in a completed Phase 2 clinical trial.

What is AL-39256, 1% used for in open-angle glaucoma?

AL-39256, 1% is being developed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is an investigational therapy and is not approved for commercial use. Its Phase 2 trial enrolled 104 patients and evaluated both safety and intraocular pressure-lowering efficacy.

Who makes AL-39256, 1%?

AL-39256, 1% is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating this ophthalmic small molecule for open-angle glaucoma and ocular hypertension.

What phase is AL-39256, 1% in?

AL-39256, 1% is in Phase 2 clinical development. Its single Phase 2 trial, NCT00761709, has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is AL-39256, 1% in?

AL-39256, 1% has been studied in one Phase 2 trial, NCT00761709, titled Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension. The trial was completed, enrolled 104 patients, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.

Is AL-39256, 1% the same as AL-39256 Ophthalmic Suspension, 1%?

Yes. AL-39256 Ophthalmic Suspension, 1% is another name for AL-39256, 1%. Both refer to the same investigational small molecule eye drop developed by Alcon Inc. for open-angle glaucoma and ocular hypertension, so searches using either name point to the same asset.