NCT02531152

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Open Angle Glaucoma -Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Latanoprost
DRUG	SAR366234

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-08-24
• Last updated: 2016-04-27

Locations

5 sites across 1 country: United States