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AL-3862+timolol

Phase 3

Glaucoma | Small molecule | Cardiovascular |Alcon Inc.|Last Updated: Jul 11, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00576342Patient Preference StudyPHASE3 COMPLETED 129Dec 1, 2007Jan 1, 2008Jul 11, 2014 -
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Study Endpoints
Primary Endpoints
Percentage of patients with a stated preference for either study medication
Day 2
Secondary Endpoints
Mean ocular discomfort score
Day 1, 1 minute after drop instillation
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AL-3862+timolol, then COSOPTOTHERAL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
COSOPT, then AL-3862+timololOTHERDorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
Interventions
NameTypeDescription
AL-3862+timolol ophthalmic suspensionDRUG -
Dorzolamide+timolol ophthalmic solutionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Sign informed consent; * Diagnosis of glaucoma or ocular hypertension; * On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy); * IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular ...

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