drugset / Trial / NCT03889886

Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)

NCT03889886 ↗

Phase 2 Completed 305 enrolled Silk Technologies, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.

Timeline

Start
2019-04-16
Primary completion
2019-10-07
Completion
2019-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject AMLISIMOD Protein / enzyme biologic 0.1 % Topical
Subject AMLISIMOD Protein / enzyme biologic 1 % Topical
Subject AMLISIMOD Protein / enzyme biologic 3 % Topical

Indications