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

PHASE2CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

April 16, 2019

Primary Completion Date

October 7, 2019

Study Completion Date

October 11, 2019

Conditions
Dry Eye
Interventions
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.

Trial Locations (26)

27262

Wake Forest Health Network Ophthalmology- Oak Hollow, High Point

30076

Coastal Research Associates, Roswell

30260

Clayton Eye Clinical Research, LLC, Morrow

33773

Shettle Eye Research, Largo

33901

Eye Associates of Fort Myers, Fort Myers

34461

West Coast Eye Institute, Lecanto

34615

Hernando Eye Institute, Brooksville

37205

Nashville Vision Associates, Nashville

38119

Total Eye Care, Memphis

38120

Eye Specialty Group, Memphis

44115

Abrams Eye Center, Cleveland

45701

Drs. Quinn, Foster & Associates, Athens

63090

Comprehensive Eye Care Ltd, Washington

63131

Ophthalmology Associates, St Louis

66204

Heart of America Eye Care, P.A., Shawnee Mission

66762

Kannarr Eye Care, Pittsburg

78240

Medical Center Ophth Assoc / Keystone Research, San Antonio

78731

Texan Eye / Keystone Research, Ltd., Austin

91345

North Valley Eye Medical Group, Mission Hills

91702

Canyon City Eyecare, Azusa

92562

LoBue Laser and Eye Medical Center, Murrieta

92663

Eye Research Foundation, Newport Beach

92843

Orange County Ophthalmology Medical Group, Garden Grove

94954

North Bay Eye Associates, Petaluma

95815

Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants, Sacramento

06810

Danbury Eye Physicians and Surgeons, PC, Danbury

All Listed Sponsors
lead

Silk Technologies, Ltd.

INDUSTRY

NCT03889886 - Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) | Biotech Hunter | Biotech Hunter