drugset / Trial / NCT04535947

Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

NCT04535947 ↗

Phase 2 Completed 153 enrolled Silk Technologies, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.

Timeline

Start
2020-08-14
Primary completion
2021-02-10
Completion
2021-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject AMLISIMOD Protein / enzyme biologic 1 % Topical

Indications