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AL-37807, 0.1%

Phase 2

Open-Angle Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Dec 5, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment336

FDA Designations

No designations recorded

Clinical trial landscape

AL-37807, 0.1% · 3 trials · 2 indications

Phase 2 3
NCT00620256Adjunctive Study of AL-37807 Ophthalmic SuspensionOpen-Angle Glaucoma
COMPLETED129 Analytics
NCT00372931A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-Angle Glaucoma
COMPLETED120 Analytics
NCT00287521A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-angle Glaucoma
COMPLETED87 Analytics
PHASE2COMPLETED
Adjunctive Study of AL-37807 Ophthalmic Suspension
Open-Angle GlaucomaUnlock trial analytics
PHASE2COMPLETED
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
Open-Angle GlaucomaUnlock trial analytics
PHASE2COMPLETED
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Open-angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in intraocular pressure
Baseline, up to 4 weeks
Mean IOP change from baseline
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL-37807EXPERIMENTALAL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
TimololACTIVE_COMPARATORTimolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807 vehiclePLACEBO_COMPARATORAL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807 SuspensionEXPERIMENTAL -
XalatanACTIVE_COMPARATOR -
Timolol MaleateEXPERIMENTAL -

Interventions

NameTypeDescription
AL-37807 ophthalmic suspension, 0.1%DRUG -
Timolol gel forming solution, 0.5%DRUG -
AL-37807 ophthalmic solution vehicleOTHER -
Latanoprost ophthalmic solutionDRUG -
AL-37807DRUG -
AL-37807 Ophthalmic Suspension, 1.0%DRUGOne drop in the study eye(s) once daily for 28 days
Latanoprost, 0.005% (Xalatan)DRUGOne drop in the study eye(s) once daily for 28 days
AL-37807 VehicleOTHEROne drop in the study eye(s) once daily for 28 days
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%DRUGOne drop in the study eye(s) once daily for 28 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Open-angle glaucoma * Ocular hypertension * Must have been on Xalatan for at least 3 months * VA not worse than 0.60 * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Age related * Other protocol-defined exclusion criteria may apply

Countries:United States
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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about AL-37807, 0.1%

What is AL-37807 used for?

AL-37807 is an investigational small molecule being developed for the treatment of open-angle glaucoma and ocular hypertension. It is formulated as a 0.1% ophthalmic suspension and has been studied in Phase 2 clinical trials in the United States.

Who makes AL-37807?

AL-37807 is being developed by Alcon Inc. (NYSE: ALC), a pharmaceutical company focused on eye care. The drug is in Phase 2 clinical development for open-angle glaucoma and ocular hypertension.

What phase is AL-37807 in?

AL-37807 is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has AL-37807 been in?

AL-37807 has been studied in three completed Phase 2 trials: NCT00287521 (87 participants), NCT00372931 (120 participants), and NCT00620256 (129 participants). All trials were conducted in the United States and enrolled adults with open-angle glaucoma or ocular hypertension.

Is AL-37807 a randomized controlled trial drug?

Yes, AL-37807 has been evaluated in randomized, double-blind, placebo-controlled Phase 2 trials. The three completed studies enrolled a total of 336 participants and compared the drug against placebo in patients with open-angle glaucoma or ocular hypertension.