Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

Summary

The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.

Timeline

Start

2012-11

Primary completion

2015-04

Completion

—

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper SYL1001 1.125% once daily produced a significant decrease in VAS scores compared with placebo reads as mixed primary results PMID 27893109 ↗

paper For all treatments, OSDI scores were significantly reduced compared to their respective baseline values (P < 0.01), although no significant changes were detected between groups. reads as mixed primary results PMID 27893109 ↗

release “SYL1001_II and SYL1001_III achieved their primary endpoints in terms of ocular pain (VAS) (p<0.016) and hyperaemia reduction” reads as met primary endpoint sylentis.com ↗

Publications

• Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SYL1001	Small interfering RNA (siRNA)	1.125 %	Topical

Indications