NCT03889886

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

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Silk Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	SDP-4 Ophthalmic Solution (0.1%)	Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
DRUG	SDP-4 Ophthalmic Solution (1.0%)	Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
DRUG	SDP-4 Ophthalmic Solution (3.0%)	Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
DRUG	Vehicle	Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.

Timeline

• Start date: 2019-04-16
• Primary completion: 2019-10-07
• Completion: 2019-10-11
• First posted: 2019-03-26
• Last updated: 2022-09-02
• Results posted: 2022-09-02

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study