Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

Phase 2 Completed 66 enrolled Sylentis, S.A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2015-06
Primary completion: 2016-03
Completion: —

Outcome

Met primary endpoint

paper These trials achieved their primary endpoints of identifying the most effective dose of SYL1001 (1.125%). PMID 27893109 ↗

release “SYL1001_II and SYL1001_III achieved their primary endpoints in terms of ocular pain (VAS) (p<0.016) and hyperaemia reduction” 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