SYL040012, Treatment for Open Angle Glaucoma

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.

Timeline

Start

2014-10

Primary completion

2015-08

Completion

2016-01

Outcome

Missed primary endpoint

registry analysis (superiority test); SYL040012 (Bamosiran) 1.125% Eye Drops vs SYL040012 (Bamosiran) 1.5% Eye Drops; p = 0.93; ANCOVA NCT02250612 ↗

registry analysis (superiority test); SYL040012 (Bamosiran) 0.75 % Eye Drops vs SYL040012 (Bamosiran) 1.5% Eye Drops; p = 0.92; ANCOVA NCT02250612 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Timolol	Other / unclassified	0.5 %	Topical
Subject	bamosiran	Unknown	0.375 %	Topical
Subject	bamosiran	Unknown	0.75 %	Topical
Subject	bamosiran	Unknown	1.125 %	Topical
Subject	bamosiran	Unknown	1.5 %	Topical

Indications