Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

January 19, 2022

Primary Completion Date

September 22, 2022

Study Completion Date

December 19, 2022

Conditions
Dry Eye
Interventions
DRUG

Oxervate

Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in both eyes three times daily (TID).

OTHER

Vehicle

Vehicle will be instilled with the same scheme of the test product

Trial Locations (10)

20123

Università degli Studi di Milano - Ospedale San Giuseppe - UO Oculistica, Milan

21218

The Johns Hopkins University, Baltimore

23502

Virginia Eye Consultants (VEC) - Norfolk Office, Norfolk

37215

Toyos Clinic - Nashville, Nashville

77025

Houston Eye Associates HEA - Gramercy Location, Houston

91204

Lugene Eye Institute - Glendale Office, Glendale

92663

David Wirta, M.D. & Associates, Newport Beach

95123

AOU Gaspare Rodolico - Ospedale San Marco, Catania

02111

Tufts University School of Medicine (TUSM) - New England Eye Center/Tufts Medical Center - Boston, Boston

00161

AOU Policlinico Umberto I - Dipartimento Organi di Senso - Clinica Oculistica, Roma

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY