Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: SYL040012 bamosiran siRNA RNAi Glaucoma Ocular hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 184
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 1 drop in each eye once daily for 28 consecutive days arm 2: 1 drop in each eye once daily for 28 consecutive days arm 3: 1 drop in each eye once daily for 28 consecutive days arm 4: 1 drop in each eye once daily for 28 consecutive days arm 5: 1 drop in each eye twice daily for 28 consecutive days

Interventions: intervention 1: 1 drop of 0.375% SYL040012 (bamosiran) intervention 2: 1 drop of 0.750% SYL040012 (bamosiran) intervention 3: 1 drop of 1.125% SYL040012 (bamosiran) intervention 4: 1 drop of 1.5% SYL040012 (bamosiran) intervention 5: 1 drop of 0.5 % timolol maleate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol document: