SYL040012, Treatment for Open Angle Glaucoma

Study purpose

The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.

Treatment groups

SYL040012 (bamosiran) 0.375% eye drops EXPERIMENTAL — 1 drop in each eye once daily for 28 consecutive days Interventions: Drug: 1 drop of 0.375% SYL040012 (bamosiran)

SYL040012 (bamosiran) 0.750% eye drops EXPERIMENTAL — 1 drop in each eye once daily for 28 consecutive days Interventions: Drug: 1 drop of 0.750% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.125% eye drops EXPERIMENTAL — 1 drop in each eye once daily for 28 consecutive days Interventions: Drug: 1 drop of 1.125% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.5% eye drops EXPERIMENTAL — 1 drop in each eye once daily for 28 consecutive days Interventions: Drug: 1 drop of 1.5% SYL040012 (bamosiran)

Timolol maleate 0.5% ophthalmic solution ACTIVE_COMPARATOR — 1 drop in each eye twice daily for 28 consecutive days Interventions: Drug: 1 drop of 0.5 % timolol maleate

Primary outcomes

Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm Time frame: Baseline and Day 28

Study design

Allocation: RANDOMIZED · Intervention model: PARALLEL · Purpose: TREATMENT · Enrollment: 184

Source: ClinicalTrials.gov · Preserved current registry observation 102562