Recent Updates
Recently added Catalysts

SAR366234

Phase 1

Open Angle Glaucoma -Ocular Hypertension | Small molecule | Ophthalmology |Sanofi|Last Updated: Apr 27, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

SAR366234 · 1 trial · 1 indication

Phase 1 1
NCT0253115228-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular HypertensionOpen Angle Glaucoma -Ocular Hypertension
COMPLETED54 Analytics
PHASE1COMPLETED
28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
Open Angle Glaucoma -Ocular Hypertension
NCT0253115254
Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events (including local tolerance and ophthalmological examinations)
From screening (Day -42) up to approximately Day 39

Secondary Endpoints

Assessment of IOP using Goldman applanation tonometry
From screening (Day -42) up to approximately Day 39
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR366234 (Dose 1)EXPERIMENTALA low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
SAR366234 (Dose 2)EXPERIMENTALA medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 3)EXPERIMENTALA medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
SAR366234 (Dose 4)EXPERIMENTALA high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 5)EXPERIMENTALA high dose of SAR366234 will be administered 2 drops per eye per day for 28 days
LatanoprostACTIVE_COMPARATORA dose of Latanoprost will be administered 1 drop per eye per day for 28 days

Interventions

NameTypeDescription
LatanoprostDRUG -
SAR366234DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion criteria: * Male or female patients ≥18 years of age. * Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion syndromes and patients with a history of narrow angle closure with a patent peripheral iridotomy) or OHT. * Documented intraocular pressure (IOP) fulfill...

Countries:United States
Unlock Eligibility Criteria