Date: 2015-08-20
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Sanofi (France)
Product: SAR366234
Action
mechanism: kinase inhibitor/mTOR inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor.
Disease: open angle glaucoma - ocular hypertension
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: This randomized, observer-masked study will evaluate the safety, tolerability and pharmacodynamics of sequential ascending 28-day repeated topical doses of SAR366234 versus latanoprost in patients with open angle glaucoma or ocular hypertension.
Primary Objective: To assess the local and systemic safety and tolerability of ascending repeated topical doses of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) as compared to latanoprost. Secondary Objective: To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in patients with OAG or OHT as compared to latanoprost. (NCT02531152)
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