drugset / Trial / NCT03889886
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMLISIMOD | Protein / enzyme biologic | 0.1 % | Topical |
| Subject | AMLISIMOD | Protein / enzyme biologic | 1 % | Topical |
| Subject | AMLISIMOD | Protein / enzyme biologic | 3 % | Topical |