Open Angle Glaucoma -Ocular Hypertension Clinical Trial
Official title:
A Randomized, Observer-masked Study of 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.
The total study duration for one patient is up to 11 weeks, including a screening period of
up to 6 weeks run-in (depending on washout requirements), a 4-week treatment period, and a
1-week follow-up period.
The study design is also a parallel cohort study to assess the safety, tolerability, and
pharmacodynamic activity of SAR366234.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment